MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHOICE; WIRE, GUIDE, CATHETER

Model Number	1960
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 182cm (5pk) choice guidewire was selected for use.However, resistance was encountered when the device was tried to cross the lesion and the tip of the wire was peeled off.The procedure was completed with another wire of same brand.There were no patient complications 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.Spring tip was found stretched and kinked.No abnormalities were noticed int the coating of the guidewire.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that coating issue occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 182cm (5pk) choice guidewire was selected for use.However, resistance was encountered when the device was tried to cross the lesion and the tip of the wire was peeled off.The procedure was completed with another wire of same brand.There were no patient complications reported.

• Brand Name: CHOICE
• 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: 15094893
• Report Number: 2124215-2022-25446
• Device Sequence Number: 14761086
• Product Code: DQX
• UDI-Device Identifier: 08714729150558
• UDI-Public: 08714729150558
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K143587
• 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): 11/14/2022

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: 12/14/2023
• Device Model Number: 1960
• Device Catalogue Number: 1960
• Device Lot Number: 0028559214
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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: Unknown
• Patient Race: Asian