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 2020-01-02 for VIEWFLEX? PLUS ICE CATHETER INTERFACE MODULE FOR VIEWMATE Z INTRACARDIAC ULTRASO 100043720 manufactured by St. Jude Medical, Inc..
[178026719]
One viewflex? Plus ice catheter interface module for viewmate z intracardiac ultrasound console was received for investigation. Trace amounts of foreign material was identified on the transducer connector port. Disassembly was performed, and heavy amounts of saline deposits were identified on numerous internal assemblies with signs of arcing between electronic components. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information provided to abbott and the investigation performed, there was fluid ingress to the internal assemblies resulting in hardware damage.
Patient Sequence No: 1, Text Type: N, H10
[178026720]
This event is being reported based on the analysis of the returned device.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2019-00259 |
| MDR Report Key | 9540330 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2011-09-02 |
| Date Added to Maude | 2020-01-02 |
| 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-ST. PAUL) |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIEWFLEX? PLUS ICE CATHETER INTERFACE MODULE FOR VIEWMATE Z INTRACARDIAC ULTRASO |
| Generic Name | ULTRASONIC PULSED DOPPLER IMAGING SYSTEM |
| Product Code | IYN |
| Date Received | 2020-01-02 |
| Returned To Mfg | 2019-10-28 |
| Model Number | 100043720 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |