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.
[181838668]
It was reported that the burr and rotawire detached and was left inside patient's body. The target lesion was located in the left anterior tibial vessel. A 1. 75mm peripheral rotalink plus and a rotawire were selected for use. During the procedure, atherectomy got through the lesion. However, when the 1. 75mm peripheral rotalink plus was taken out, it was noted that the burr head was not moving. After retracting the entire catheter, the burr head is still inside. Then, when the rotawire was taken out, the physician further noted that a piece of the wire and the burr head were left inside the patient. Consequently, the physician tried to snare the fragments out; however, it was unable to be snared so the physician completed the procedure to make sure the patient still had runoff in the foot and they were done. The procedure was completed with the same device. The physician talked with the patient and they may have to take him to surgery to take it out. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02424 |
| MDR Report Key | 9781374 |
| 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 | 2019-07-23 |
| 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 | 0024152633 |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-03-03 |