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 2020-03-19 for VIEWFLEX? XTRA ICE CATHETER D087031 manufactured by St. Jude Medical, Inc..
[187929566]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported liver perforation could not be conclusively determined. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[187929567]
During a cryo atrial fibrillation procedure, a liver perforation occurred. The day following the ablation procedure, the patient presented with abdominal pain during follow up. A blood transfusion was administered to treat the perforation and pain near the liver, requiring extended hospital stay. The physician inserted the ice catheter as expected, felt resistance, however proceeded. The physician indicated the catheter stiffness as the cause for the perforation. The patient recovered with no longer term complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030404-2020-00019 |
| MDR Report Key | 9857824 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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, INC.(AF-IRVINE) |
| Manufacturer Street | 2375 MORSE AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIEWFLEX? XTRA ICE CATHETER |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-19 |
| Model Number | D087031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 2375 MORSE AVE IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |