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	10/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device got stuck on the wire.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior tibial artery.A 1.75 peripheral rotalink plus and a rotawire was selected for use.The vessel was pre-dilated first with a 2.5mm x 220mm coyote balloon.During the procedure, it was noted that a 1.75mm peripheral rotalink plus was spinning when it got stuck on the rotawire.Difficulty in advancing the catheter was encountered as it was stuck to the wire, so the rotalink burr was removed together with the rotawire with no difficulties.The procedure was completed with a different device.No complications reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The rotawire was removed with little restriction due to wire kinks.The advancer, handshake connections, sheath, coil, burr and annulus were microscopically exanimated.The coil is stretched.
Event or Problem Description
It was reported that device got stuck on the wire.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior tibial artery.A 1.75 peripheral rotalink plus and a rotawire was selected for use.The vessel was pre-dilated first with a 2.5mm x 220mm coyote balloon.During the procedure, it was noted that a 1.75mm peripheral rotalink plus was spinning when it got stuck on the rotawire.Difficulty in advancing the catheter was encountered as it was stuck to the wire, so the rotalink burr was removed together with the rotawire with no difficulties.The procedure was completed with a different device.No complications reported and the patient was fine post procedure.

• 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: 9280791
• Report Number: 2134265-2019-13358
• Device Sequence Number: 11323936
• 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): 12/06/2019

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 Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024179621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: BALLOON - COYOTE; BALLOON - COYOTE
• Patient Age: 71 YR