MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40456
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Stenosis (2263); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire coating issue and vessel occlusion occurred.The target lesion was located in the peroneal artery.A 300cm v-14 control wire was advanced and placed into the lesion.However, during removal through the 3.0mm x 80mm x 150cm coyote balloon catheter lumen, the coating of the guidewire sheared off and was confirmed during visual inspection.Resistance was felt during removal of the wire through the balloon.The physician remove the balloon catheter.There was a good distal run-off flow in the peroneal artery.After the intervention, the physician did another distal run-off of the peroneal artery to see if the coating occluded the vessel and it did.So, the physician perform balloon angioplasty where the coating was sitting.After that, another run-off was performed.This time, good blood flow was established.The peeled off coating was not removed from the patient's body.The procedure was completed and the patient was sent home the same day.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original box, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The guidewire returned together with its original opened cardboard box.The distal tip polymer jacket had a detached section; the damaged section was located approximately at 117.5 inches from the proximal end.The guidewire had the distal tip bent, however, this is not consider as a failure due to the configuration of this guidewire includes an angled tip.No more visual damages were found in the device.The outer diameter (od) of the middle section and proximal section were within specifications.The od of the overall length and the distal tip were not within specifications due to the detached polymer jacket.
Event or Problem Description
It was reported that guidewire coating issue and vessel occlusion occurred.The target lesion was located in the peroneal artery.A 300cm v-14 control wire was advanced and placed into the lesion.However, during removal through the 3.0mm x 80mm x 150cm coyote balloon catheter lumen, the coating of the guidewire sheared off and was confirmed during visual inspection.Resistance was felt during removal of the wire through the balloon.The physician remove the balloon catheter.There was a good distal run-off flow in the peroneal artery.After the intervention, the physician did another distal run-off of the peroneal artery to see if the coating occluded the vessel and it did.So, the physician perform balloon angioplasty where the coating was sitting.After that, another run-off was performed.This time, good blood flow was established.The peeled off coating was not removed from the patient's body.The procedure was completed and the patient was sent home the same day.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10574554
• Report Number: 2134265-2020-13092
• Device Sequence Number: 3344838
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• 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): 10/26/2020

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: 08/07/2022
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0025828439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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