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 2020-03-03 for PERIPHERAL ROTALINK PLUS 29720 manufactured by Boston Scientific Corporation.
[181830830]
It was reported that blood leaked from the rotaburr sheath. The multiple tight stenosed target lesion was located in the moderately tortuous and approximately 250mm in length of extremely heavy calcified superficial femoral and popliteal artery. A 2. 00mm peripheral rotalink plus was selected for use. During procedure, after transversing about 100mm of the heavily calcified superficial femoral artery, it was noticed that the device stopped functioning correctly and blood was leaking out of the device. The rotalink plus was removed over the rotawire from inside the patient with no issues other than the device was leaking with blood/saline. This was after use of about 2-3 minutes in the patient. It was thought that the rotalink was punctured by a sharp calcification. The procedure was completed with another of the same device. No patient complications were reported and patient was good post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02430 |
| MDR Report Key | 9780975 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-03-03 |
| 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 | 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 | PERIPHERAL ROTALINK PLUS |
| Generic Name | CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code | MCW |
| Date Received | 2020-03-03 |
| Model Number | 29720 |
| Catalog Number | 29720 |
| Lot Number | 0024484929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-03 |