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

Model Number	40456
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.Date of event: used the first day of the month of the bsc aware date since the provided event date was 16 days late from the bsc aware date.The complaint device was not returned by the customer, nevertheless the customer did provide pictures related to the complaint, where is possible to observe in the pictures that the distal tip section of the core wire exposed due to the polymer jacket detached.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
Reportable based on device analysis completed on 27-dec-2021.It was reported that tip damage occurred.During unpacking of a 300cm v-14 control wire, the tip was found to be damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, device analysis revealed distal tip detachment.
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 returned device matches with upn provided by the customer.Guidewire was visually inspected, and it was noticed that distal tip was kinked and it has the polymer jacket was detached from the distal tip section, the polymer section detached was returned with the device.Additionally, the distal end was observed kinked.No more visual damages were found in the device.Distal tip was kinked and the polymer jacket detached was confirmed under microscope inspection.It was observed that the polymer detached was not loose, it just was separated from the corewire.Detailed pictures of the distal end area were captured.The outer diameter of distal tip, middle of the device, and the proximal section are within specifications.The customer did provide pictures related to the complaint, where is possible to observe in the pictures that the distal tip section of the core wire exposed due to the polymer jacket detached.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.A2: age at time of event - 18 years or older.B3: date of event: used the first day of the month of the bsc aware date since the provided event date was 16 days late from the bsc aware date.
Event or Problem Description
Reportable based on device analysis completed on 27-dec-2021.It was reported that tip damage occurred.During unpacking of a 300cm v-14 control wire, the tip was found to be damaged.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, device analysis revealed distal tip detachment.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13315941
• Report Number: 2134265-2021-16705
• Device Sequence Number: 11947115
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 01/29/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0026722258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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: Male