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

Model Number	29710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the guide wire fractured.The target lesion was located in the left lower extremity.Peripheral rotawire was selected for use.After a successful atherectomy procedure, it was noted that the wire broke when the non- bsc balloon was removed from the patient's body.The broken wire was then removed using a snare and the procedure was completed.It was confirmed that there were no device fragments left inside the patient's body.No further complications were reported and the patient is fine.
Additional Manufacturer Narrative
Age at time of event: 18 years or older device was evaluated by the manufacturer.The device was returned for analysis.The unit returned has wire broken, as part of overall visual revision.The wire was broken on 270cm from proximal to broken section and 60cm from distal to broken section, overall should be 330 cm, therefore no piece is missing.Additionally, the wire was severely kinked along its body.Dimensional inspection of the wire dimensions that could be measured were performed and were within specification.
Event or Problem Description
It was reported that the guide wire fractured.The target lesion was located in the left lower extremity.Peripheral rotawire was selected for use.After a successful atherectomy procedure, it was noted that the wire broke when the non- bsc balloon was removed from the patient's body.The broken wire was then removed using a snare and the procedure was completed.It was confirmed that there were no device fragments left inside the patient's body.No furhter complications were reported and the patient is fine.

• 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: 8696032
• Report Number: 2134265-2019-06854
• Device Sequence Number: 1889427
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: 08714729863649
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0023557643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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- COOK MONORAIL; BALLOON- COOK MONORAIL; BALLOON- COOK MONORAIL
• Outcome Attributed to Adverse Event: Required Intervention