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

Model Number	40458
Medical Device Problem Codes	Contamination (1120); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.Upon opening of a 300cm long taper angled tip v-14 control wire guidewire, it was noted that the top of the sterile sleeve was damaged and seen to be no longer sterile.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process the device was inspected according to procedure, peripheral intervention product analysis guidelines.The guidewire was returned, and it was observed kinked at proximal tip.No more damages were observed.It is important to know that the package of the device was not returned.The device was soaked in saline solution in order to activate the coating at distal section.When the coating was activated, no issues were identified in the distal tip coating.The guidewire was returned, and it was observed kinked at proximal tip.No more damages were observed.The device was measured in three sections (distal - medium - proximal) along it.
Event or Problem Description
It was reported that device sterility was compromised.Upon opening of a 300cm long taper angled tip v-14 control wire guidewire, it was noted that the top of the sterile sleeve was damaged and seen to be no longer sterile.The procedure was completed with another of the same device.No patient complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15542729
• Report Number: 2124215-2022-37727
• Device Sequence Number: 17607777
• Product Code: DQX
• UDI-Device Identifier: 08714729799276
• UDI-Public: 08714729799276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2024
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0029446125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown