MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-01-03 for BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM 006173P manufactured by C.r. Bard, Inc. (covington) -1018233.
[178645238]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[178645239]
It was reported that damage was found on the balloon of the temporary pacing electrode catheter prior to placement. It was later reported via email on 19 december 2019 from the international business center representative, that a small hole was found on the balloon, which allegedly caused leaks during pretest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00037 |
| MDR Report Key | 9544021 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-01-03 |
| Date of Report | 2020-02-19 |
| Date of Event | 2019-11-07 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-01-03 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON BIPOLAR TEMPORARY PACING ELECTRODE, 5FR 110CM |
| Generic Name | BALLOON FLOW-ASSISTED TEMPORARY PACING ELECTRODE CATHETER |
| Product Code | LDF |
| Date Received | 2020-01-03 |
| Model Number | 006173P |
| Catalog Number | 006173P |
| Lot Number | GFDT2481 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |