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

Model Number	29711
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rotawire broke and was snared to remove.Vascular access was obtained via anterior tibial (at) artery.A peripheral rotawire guidewire was selected for use.During the procedure, the rotawire was used for successful atherectomy of the at artery and superficial femoral artery (sfa), and was then used as a rail to balloon the at artery.When removing the balloon, the non-bsc sheath came out of the access point out of the body.When trying to reinsert the sheath over the rotawire, the sheath was unable to advance.The rotawire was manipulated several times.It was pulled back, looped, and kinked on itself.The rotawire broke in half inside the patient body.Contralateral access was obtained in the left common femoral artery (cfa).A snare was successfully used to remove the remaining rotawire inside the patient body.The procedure was completed with a different device.There was no harm to the patient.
Additional Manufacturer Narrative
Device evaluated by manufacturer: unit was returned and the guidewire is severely kinked.A portion of the distal end including the spring tip was not returned since the guidewire is fractured.Guidewire fracture confirmed.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.Overall length and o.D.Distal measurements could not be performed due to device condition (fractured).The o.D.Medium and o.D.Proximal were found within specification.
Event or Problem Description
It was reported that the rotawire broke and was snared to remove.Vascular access was obtained via anterior tibial (at) artery.A peripheral rotawire guidewire was selected for use.During the procedure, the rotawire was used for successful atherectomy of the at artery and superficial femoral artery (sfa), and was then used as a rail to balloon the at artery.When removing the balloon, the sheath came out of the access point out of the body.When trying to reinsert the sheath over the rotawire, the sheath was unable to advance.The wire was manipulated several times.It was pulled back, looped, and kinked on itself, finally snapping in half inside the patient's body.Contralateral access was obtained in the left common femoral artery (cfa).A snare was successfully used to remove the remaining wire inside the patient's body.The procedure was completed with a different device.There was no harm 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: 12359616
• Report Number: 2134265-2021-10682
• Device Sequence Number: 3794314
• Product Code: MCW
• UDI-Device Identifier: 08714729838890
• UDI-Public: 08714729838890
• 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
• 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): 09/30/2021

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: 03/15/2023
• Device Model Number: 29711
• Device Catalogue Number: 29711
• Device Lot Number: 0026971893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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: INTRODUCER SHEATH - TERUMO GLIDESHEATH SLENDER; INTRODUCER SHEATH - TERUMO GLIDESHEATH SLENDER; INTRODUCER SHEATH - TERUMO GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Required Intervention