MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-26 for NC QUANTUM APEX 6531 manufactured by Boston Scientific Corporation.
[185212722]
Age at time of event: 18 years or older. Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was contrast in the inflation lumen and blood in the guidewire lumen. The balloon was loosely folded. Inspection of the device revealed numerous kinks throughout the hypotube and there was a complete hypotube separation 43. 5cm distal of the strain relief. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. Also, the tip was damaged.
Patient Sequence No: 1, Text Type: N, H10
[185212723]
Reportable based on device analysis completed on 03/05/2020. It was reported that the shaft was damaged. A 12mm x 2. 50mm nc quantum apex was selected however, during unpacking, it was noted that the shaft was damaged. The procedure was completed with a different device. No patient complications were reported and patient status was stable. However, device analysis revealed a shaft break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03500 |
| MDR Report Key | 9884870 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-04-08 |
| Date Added to Maude | 2020-03-26 |
| 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 | NC QUANTUM APEX |
| Generic Name | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Product Code | LOX |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-15 |
| Model Number | 6531 |
| Catalog Number | 6531 |
| Lot Number | 0023607075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-26 |