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 2020-03-18 for ROTALINK BURR 3320 manufactured by Boston Scientific Corporation.
[183930445]
Device evaluated by manufacturer: the device was returned for analysis. The sheath, coil, burr and annulus were visually and microscopically examined. The distal end of the sheath is stretched, twisted and completely torn 6mm from the distal end of the burr. The separated /torn sheath is stuck on the burr. Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire. The coil is stretched. Inspection of the remainder of the device presented no other damage or irregularities.
Patient Sequence No: 1, Text Type: N, H10
[183930446]
Reportable based on device analysis completed on (b)(6) 2020. It was reported that the device could not cross the lesion. The stenosed target lesion was located in the severely calcified left main coronary artery. A 1. 50mm rotalink burr was selected for use. During procedure, it was noted that the burr could not cross the lesion due to severe calcification. The procedure was completed with another of the same device. No patient complications were reported and the patient was stable. However, device analysis revealed the sheath was torn 6mm from the distal end of the burr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03505 |
| MDR Report Key | 9847570 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2018-12-17 |
| Date Added to Maude | 2020-03-18 |
| 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 CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTALINK BURR |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 3320 |
| Catalog Number | 3320 |
| Lot Number | 0023092221 |
| 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 | 2020-03-18 |