MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for PRONTO IPN913541 5040 manufactured by Teleflex Incorporated.
[183897458]
Attempted to put in pronto catheter for pulmonary thrombectomy and catheter tip broke off. Manufacturer response for pronto extraction catheter, pronto (per site reporter). Pending response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847465 |
| MDR Report Key | 9847465 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-21 |
| Report Date | 2020-01-24 |
| Date Reported to FDA | 2020-01-24 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRONTO |
| Generic Name | CATHETER, EMBOLECTOMY |
| Product Code | DXE |
| Date Received | 2020-03-18 |
| Model Number | IPN913541 |
| Catalog Number | 5040 |
| Lot Number | 664387 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |