MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-08 for PACEL BIPOLAR PACING CATHETER 401766 manufactured by St. Jude Medical.
[174188331]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[174188332]
During the crt-d insertion procedure on a patient with low ejection fraction, a pericardial effusion from a suspected cardiac perforation occurred, causing the patient to expire. The pacing catheter was in the heart for five days using internal jugular access. The threshold had been going up and the output kept being increased. When the threshold went up, the pacing catheter was moved to a better location. The rv lead was successfully implanted and the 3830 mdt lead was just starting to be placed in the heart. Soon after the temporary wire was removed, the patient? S pressure started dropping. Fluoroscopy showed the pacing catheter outside of the cardiac silhouette. The 3830 lead was immediately removed from the body and a pericardiocentesis was performed. 30-45 minutes after the first drop in blood pressure was noticed and during the middle of the pericardiocentesis, the patient? S blood pressure dropped again and the patient ventricular fibrillation arrested. External shocks could not convert the patient? S rhythm, and despite chest compression and multiple attempted defibrillation shocks, the patient did not survive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182269-2020-00003 |
| MDR Report Key | 9565558 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-08 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-01-08 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 553452126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553452126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACEL BIPOLAR PACING CATHETER |
| Generic Name | ELECTRODE, PACEMAKER, TEMPORARY |
| Product Code | LDF |
| Date Received | 2020-01-08 |
| Model Number | 401766 |
| Catalog Number | 401766 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 553452126 US 553452126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-08 |