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 2020-01-28 for COMET 8900 manufactured by Boston Scientific Corporation.
[176657206]
It was reported that a tip detachment occurred. A percutaneous coronary intervention was being performed. Vascular access was obtained via the radial artery. It was noted that the ostial lesion of the brachio-cephalic branch was 50% stenosed. A 6fr non-bsc guide catheter along with this comet pressure guidewire were advanced. The first lesion that was evaluated was 60% stenosed, slightly calcified, non-tortuous,15mm in length and located in the left anterior descending. The second lesion that was evaluated was a 70-90% stenosed, calcified short ostial lesion located in the circumflex. The third lesion that was evaluated was 70-90% stenosed and located in the non-tortuous, calcified, 3-5mm in length intermediate branch. While attempting to cross the third lesion they noticed that the distal tip of the comet pressure guidewire separated inside the guide catheter. There was no resistance met when the guidewire stop rotating, and the tip of the guide catheter maintain position in the ostium during the entire procedure. The comet guidewire had been removed from the patient for reshaping but did not become kinked or prolapsed. The distal tip was removed by trapping it inside the guide catheter with 3. 0x15mm nc balloon at 20atm. The distal tip and guide catheter were removed together. All parts of the wire were retrieved from the patients body. No patient complications were reported that the patient status is stable. .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00360 |
| MDR Report Key | 9638861 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-28 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-12-11 |
| Date Added to Maude | 2020-01-28 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMET |
| Generic Name | TRANSDUCER, PRESSURE, CATHETER TIP |
| Product Code | DXO |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-31 |
| Model Number | 8900 |
| Catalog Number | 8900 |
| Lot Number | 0023066373 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-28 |