MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BACK-UP MEIER; WIRE, GUIDE, CATHETER

Model Number	41488
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire coating peeled off.A.035in, 185cm, j tip, b5 back-up meier guidewire was used during the procedure.However, multiple places of the guidewire coating peeled off.The device was removed and no coating/wire fragments were left inside the patient's body.The procedure was completed successfully.There were no patient complications reported.
Event or Problem Description
It was reported that guidewire coating peeled off.A.035in, 185cm, j tip, b5 back-up meier guidewire was used during the procedure.However, multiple places of the guidewire coating peeled off.The device was removed and no coating/wire fragments were left inside the patient's body.The procedure was completed successfully.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch batch.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.It was observed that the ptfe of the guidewire was peeled off at several parts of the device.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: BACK-UP MEIER
• 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: 14959652
• Report Number: 2134265-2022-07261
• Device Sequence Number: 5497670
• Product Code: DQX
• UDI-Device Identifier: 08714729227885
• UDI-Public: 08714729227885
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020283
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 04/28/2024
• Device Model Number: 41488
• Device Catalogue Number: 41488
• Device Lot Number: 0029315086
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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