MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTALINK PLUS; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr stuck on wire.The target lesion was located in the right anterior tibial artery down in the leg.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that the burr stuck on the wire upon spinning.The devices were pulled out together out of the patient's body as the burr could not be remove over the wire.Rewiring was done and the procedure was completed with balloon angioplasty, end result was great.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The returned product consisted of a rotablator plus device.The advancer unit and burr catheter were received together along with rotawire in the device.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically examined.The rotawire was removed from the device with no issue or restriction.The coil is stretched.The returned rotawire was re-inserted through the burr and advanced through the entire length of the device with no resistance.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr stuck on wire.The target lesion was located in the right anterior tibial artery down in the leg.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that the burr stuck on the wire upon spinning.The devices were pulled out together out of the patient's body as the burr could not be remove over the wire.Rewiring was done and the procedure was completed with balloon angioplasty, end result was great.No patient complications were reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9633110
• Report Number: 2134265-2020-00518
• Device Sequence Number: 16932604
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/06/2020

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: 09/11/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024421605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROTAWIRE; ROTAWIRE
• Patient Age: 72 YR