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

Model Number	29710
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spring tip broke.The target lesion was located in a small collateral branch.A peripheral rotawire was selected for use.During procedure, it was noted that the spring tip was broken.The distal tip of the wire was left inside the patient's body and was not snared as it was located in a small branch.It was not attempted to be retrieved and no intervention was done.No complications manifested to the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the device has the distal tip broken/fractured approximately at 328.4 cm from the proximal end; the detached section was not returned.The guidewire body was kinked approximately at 236 cm from the proximal end.No more damages were found.Dimensional inspection revealed that the overall length and outer diameter (od) of the distal tip could not be performed due to device condition.The od of the middle and proximal section of the deice were within specifications.
Event or Problem Description
It was reported that the spring tip broke.The target lesion was located in a small collateral branch.A peripheral rotawire was selected for use.During procedure, it was noted that the spring tip was broken.The distal tip of the wire was left inside the patient's body and was not snared as it was located in a small branch.It was not attempted to be retrieved and no intervention was done.No complications manifested to the patient.

• 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: 9010602
• Report Number: 2134265-2019-11066
• Device Sequence Number: 19464999
• 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: P900056
• 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): 10/16/2019

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 Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0023933983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other