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

Model Number	29720
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire was fractured.The 60% stenosed target lesion was located in the moderately calcified and not very tortuous straight segment in the mid-distal anterior tibial.During the procedure, resistance was felt upon advancing and it was noted that the wire fractured into two pieces.The devices were pulled together and the physician had to re-position a new wire and used a whole new device to complete the procedure.Per client, it felt that the break was on ether entire time, difficult to pass or retrieve wire.There was no injury reported and the patient is safe, and healthy.
Event or Problem Description
It was reported that the wire was fractured.The 60% stenosed target lesion was located in the moderately calcified and not very tortuous straight segment in the mid-distal anterior tibial.During the procedure, resistance was felt upon advancing and it was noted that the wire fractured into two pieces.The devices were pulled together and the physician had to re-position a new wire and used a whole new device to complete the procedure.Per client, it felt that the break was on ether entire time, difficult to pass or retrieve wire.There was no injury reported and the patient is safe, and healthy.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the annulus of the burr was damaged/not rounded.The damage to the annulus is consistent to interaction with the rotawire during rotation.The wire used in the procedure was not returned, so analysis was performed using a test wire.The rotawire was not able to be inserted into the annulus due to the annulus no longer being round, restricting the wire.

• 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: 12605989
• Report Number: 2134265-2021-12682
• Device Sequence Number: 13806705
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 12/04/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0026464835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1