MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 12TLW405F35 manufactured by Edwards Lifesciences Pr.
[186023436]
The device was not returned for evaluation due to hospital policy. However, the customer will send a photograph for evaluation purposes. A supplemental report will be forthcoming with any additional information. A review of the manufacturing records indicated that the product met specifications upon release. Udi# ((b)(4) # mw5092368.
Patient Sequence No: 1, Text Type: N, H10
[186023437]
It was reported that during embolization procedure on a (b)(6) female patient for an av fistula, the balloon on the catheter ruptured while using a 5 fr embolectomy catheter. When the catheter was removed from the vascular site, the balloon was no longer attached. No apparent complications reported. Further follow up with the customer stated the device will not be sent but they are willing to provide photos. Edwards lifesciences was notified of the event by a (b)(4) report.
Patient Sequence No: 1, Text Type: D, B5
[186023729]
A photo provided by the customer was reviewed and the reported event of "balloon on the catheter ruptured" was confirmed from the images. Two images were reviewed. Images showed a fogarty through lumen catheter in a biohazard bag. Red spots appeared to be blood were observed on the catheter tip, the through lumen hub and the gate valve. The balloon appeared to be ruptured between the balloon bushings. A white spot, that appeared to be catheter body was observed from under the ruptured balloon, between the balloon bushing. The images were not clear to confirm if the balloon edges matched at the ruptured location. The reported event of detached balloon was not able to be confirmed from the images as the images were not clear. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. The fogarty thru-lumen embolectomy catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The thru-lumen embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material such as chronic clot or atherosclerotic plaque. The catheter is not designed to withstand the additional pull force needed to remove these materials. The ifu for the product contains the following warning: balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures. The possibility of balloon rupture must be taken into account when considering the risks involved in any embolectomy procedure. To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2020-10982 |
| MDR Report Key | 9838144 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS LYNN THOMAS |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES PR |
| Manufacturer Street | STATE RD INDUS PK 402 KM 1.4 |
| Manufacturer City | ANASCO PR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-16 |
| Model Number | 12TLW405F35 |
| Catalog Number | 12TLW405F35 |
| Lot Number | 62667400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES PR |
| Manufacturer Address | STATE RD INDUS PK 402 KM 1.4 ANASCO PR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |