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 2020-01-17 for TEMPO TEMPORARY PACING LEAD TC1106 manufactured by Biotrace Medical, Inc..
[189005153]
During the procedure the patient experienced a pericardial effusion. Dr. (b)(6) who placed the tempo lead stated that he believed that the perforation occurred during the initial placement of the tempo lead. This is supported by his statement that the tempo lead was placed "way out" to the apex of the right ventricle and in spite of this typically optimal position, pace capture could not be attained. Dr. (b)(6) repositioned the tempo lead twice and was ultimately able to obtain a capture threshold below 1ma (generally considered optimal). Subsequent to placement of the lead the patient was noted to be hypotensive, which was ultimately determined to be related to a pericardial effusion. Surgery was performed on the patient to close a small perforation in the apex of the heart. Dr (b)(6) stated that he used the introducer aid to advance the tempo lead into the introducer sheath and that he did not have any difficulty during tempo lead insertion or placement. He stated that the soft tip looked normal at the time of the final position in the apex of the right ventricle and was not kinked or "offset". He also stated that the patient was (b)(6) and at risk of an apical perforation by virtue of his age and morbidities. While the soft tip of the tempo lead appeared to be damaged, it is not known if the device malfunctioned or if there was misuse of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013472601-2020-00001 |
| MDR Report Key | 9603633 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2019-06-13 |
| Date Added to Maude | 2020-01-17 |
| 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 | MR. KEN XAVIER |
| Manufacturer Street | 3925 BOHANNON DR. SUITE #200 |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer G1 | BIOTRACE MEDICAL, INC. |
| Manufacturer Street | 3925 BOHANNON DR. SUITE #200 |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPO TEMPORARY PACING LEAD |
| Generic Name | TEMPO TEMPORARY PACING LEAD |
| Product Code | LDF |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2019-12-23 |
| Model Number | TC1106 |
| Catalog Number | TC1106 |
| Lot Number | 31035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRACE MEDICAL, INC. |
| Manufacturer Address | 3925 BOHANNON DR. SUITE #200 MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-01-17 |