MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-10 for VIEWFLEX? XTRA ICE CATHETER D087031 manufactured by St. Jude Medical, Inc..
[187931939]
Investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[187931940]
During the procedure, difficulty was noted when inserting the catheter through the femoral vein. The device was advanced into the right atrium however the image was not as expected. The device was removed and the tip was fractured. The device was replaced and the procedure was completed with no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030404-2020-00009 |
| MDR Report Key | 9687778 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-06-12 |
| Date Added to Maude | 2020-02-10 |
| 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. |
| 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 | 2020-02-10 |
| Returned To Mfg | 2020-02-25 |
| Model Number | D087031 |
| Catalog Number | D087031 |
| Lot Number | 7026568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-10 |