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 2020-03-27 for SWARTZ? INTRODUCER, UNKNOWN manufactured by St. Jude Medical.
[186599004]
The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was not reviewed as the batch number was not available. Based on the information received, the cause of the reported incident 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
[186599005]
Related manufacturing reference: 3005334138-2020-00134, 3005334138-2020-00138. During a cryoablation typical atrial flutter procedure a pericardial effusion occurred. The patient was hemodynamically stable for the duration of the procedure, however; after the case a pericardial effusion was diagnosed via echocardiography. The patient was transferred to surgically repair a perforation in the cavotricuspid isthmus. Following surgery the patient was stable. There were no performance issues with any abbott device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005334138-2020-00135 |
| MDR Report Key | 9888450 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| 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 | 2020-03-27 |