MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-03 for POWERWIRE RADIOFREQUENCY GUIDEWIRE KIT EWK35-250-12-6A-30-05 manufactured by Baylis Medical Company Inc..
[188991667]
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release. There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident. However, as the baylis device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report. There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure.
Patient Sequence No: 1, Text Type: N, H10
[188991668]
During a procedure in which the powerwire radiofrequency guidewire kit was used, it was suspected that a tamponade occurred. The physician attempted to cross an occluded superior vena cava (svc) with the powerwire and was successful. Fifteen minutes later, while introducing other wires, sheaths and a balloon into the patient, the patient's status deteriorated and a code was called. The physician believed that a tamponade occurred. Various healthcare professionals were called to assist with the complication. Chest compressions were performed on the patient. The patient regained their pulse and was reported to now be doing fine. There is no evidence to suggest that a baylis medical device caused or contributed to the reported incident. However, as baylis medical device were reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2020-00001 |
| MDR Report Key | 9548583 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2019-12-06 |
| Date Added to Maude | 2020-01-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MEGHAL KHAKHAR |
| Manufacturer Street | 2775 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4W 4P7 |
| Manufacturer G1 | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Street | 2775 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4W 4P7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERWIRE RADIOFREQUENCY GUIDEWIRE KIT |
| Generic Name | PERCUTANEOUS CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-03 |
| Model Number | EWK35-250-12-6A-30-05 |
| Lot Number | EKFA040419 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Address | 5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-03 |