MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29711
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The rotawire was able to be removed from the rotablator plus device with little issue.There are numerous kinks along the wire.It was unable to determine if the returned device matches with upn provided by the customer, as no packaging was received with the devices and the upn is unknown.The wire was able to be removed from the device with little restriction/issue due to the numerous wire kinks.There are numerous kinks along the body of the rotawire.It was inspected according to procedure.Dimensional inspection of the device that could be measured were performed and were within specifications.
Event or Problem Description
It was reported that the burr was unable to retract over the wire.The target lesion was located in the severely calcified superficial femoral artery (sfa).A 2.00mm peripheral rotalink plus and a peripheral rotawire were selected for use.During procedure, the burr stalled on two occasions.Subsequently, upon withdrawal, it was noted that the burr could not be retracted over the rotawire.The devices were able to be removed as a single unit from the patient's body, but lost wire access wire across the lesion.A new access was obtained and successful angioplasty was performed to complete procedure.There were no patient complications reported.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10875421
• Report Number: 2134265-2020-16088
• Device Sequence Number: 17085299
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2021
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0024777799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR