MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in the non-tortuous but calcified superficial femoral artery and infra-popliteal artery.A 200cm, 8cm poly tip v-18 control wire was advanced for navigating and delivery.However, upon checking final angiography, it was observed that the wire black polymer distal tip was totally separated about 3cm into the patient body.The detached tip was removed from the patient body through snaring device.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was normal.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The target lesion was located in the non-tortuous but calcified superficial femoral artery and infra-popliteal artery.A 200cm, 8cm poly tip v-18 control wire was advanced for navigating and delivery.However, upon checking final angiography, it was observed that the wire black polymer distal tip was totally separated about 3cm into the patient body.The detached tip was removed from the patient body through snaring device.The procedure was completed with another of same device.There were no patient complications reported, and the patient condition was normal.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned with its original pouch.The unit returned has the tip damaged and part of it detached, as part of overall visual revision.The returned guidewire had the wire kinked at distal tip section.Additionally, the core wire exposed due to the polymer jacket peeled.The distal tip was confirmed kinked and polymer peeled under microscope.The very tip is without detachment or exposed tip.The peeled section related to polymer was measured and 3.9cm were missing.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12212141
• Report Number: 2134265-2021-09351
• Device Sequence Number: 3210224
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 02/24/2023
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0026869553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: Required Intervention