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	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the burr seized on the rotawire.Vascular access was via contralateral approach.The target lesion was located in the tibial artery.A 1.50mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that the rotaburr seized on the rotawire and the physician could not advance the burr.The devices were removed from the patient's body and the procedure was completed with balloon angioplasty.No patient complications were reported.
Event or Problem Description
It was reported that the burr seized on the rotawire.Vascular access was via contralateral approach.The target lesion was located in the tibial artery.A 1.50mm peripheral rotalink plus and a rotawire were selected for use.During procedure, it was noted that the rotaburr seized on the rotawire and the physician could not advance the burr.The devices were removed from the patient's body and the procedure was completed with balloon angioplasty.No patient complications were reported.
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.The returned complaint device consisted of a rotablator plus device and wire for related complaint inside the device.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual and microscopic examination revealed no damages.The wire was able to be removed with resistance at kinks.The wire was able to be reinserted but resistance at kinks.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10105813
• Report Number: 2134265-2020-07199
• Device Sequence Number: 14207467
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/16/2020

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: 01/06/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0025001061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1