MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-31 for SWARTZ? INTRODUCER, UNKNOWN manufactured by St. Jude Medical.
[186599414]
Concomitant device(s): swartz introducer, brk transseptal needle, flexability ablation catheter, tacticath quartz ablation catheter, inquiry optima diagnostic loop catheter. The results of the investigation are inconclusive since the device was not returned for analysis. Additionally, no lot number was provided so a review of the device history record (dhr) was not possible. Based on the information received, the cause of the reported incidents could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10
[186599415]
Related manufacturing ref: 3005334138-2020-00145, 3008452825-2020-00176, 9680001-2020-00016, 3005334138-2020-00146, 2030404-2020-00023. In an article published in wiley, journal of arrhythmia, titled, "the impact of the presence of left atrial low voltage areas on outcomes from pulmonary vein isolation" by ahmed-jushuf, fiyyaz et al. : four (2. 5%) patients experienced major procedural complications comprising of a mitral valve injury because of the multipolar mapping catheter entrapment (n = 1), pericardial effusion requiring percutaneous drainage (n = 2), and a right leg pseudoaneurysm (n = 1).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00144 |
| MDR Report Key | 9902657 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-31 |
| 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 | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SWARTZ? INTRODUCER, UNKNOWN |
| Generic Name | TRANSSEPTAL CATHETER INTRODUCER |
| Product Code | DYB |
| Date Received | 2020-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |