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 2020-03-25 for INQUIRY? STEERABLE DIAGNOSTIC CATHETER IBI-81174 manufactured by St. Jude Medical, Costa Rica Ltda.
[186574153]
One decapolar, inquiry steerable diagnostic catheter was received for evaluation. The device was returned due to a display issue. Electrode 4 read as an open circuit. A biological foreign material was noted covering electrode 4, interfering with the conductivity of the electrode and consistent with the open circuit detected and the reported display issue. Electrodes 1-3 and 5-10 met specifications of acceptable resistance values. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the electrical issue is due to the biological foreign material covering the electrode.
Patient Sequence No: 1, Text Type: N, H10
[186574154]
This report is to advise of an event observed during analysis, confirming tissue on the returned device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00164 |
| MDR Report Key | 9880390 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-10-04 |
| Date Added to Maude | 2020-03-25 |
| 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, COSTA RICA LTDA |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INQUIRY? STEERABLE DIAGNOSTIC CATHETER |
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
| Product Code | DRF |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-02-04 |
| Model Number | IBI-81174 |
| Catalog Number | IBI-81174 |
| Lot Number | 7211538 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |