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

Model Number	2779
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating problem occurred.A 185cm straight, pt2 guidewire was selected for use.However, during preparation, it was noted that the guidewire was kinked and there was a problem with the coating.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that a coating problem occurred.A 185cm straight, pt2 guidewire was selected for use.However, during preparation, it was noted that the guidewire was kinked and there was a problem with the coating.The procedure was completed with another of same device.There were no patient complications nor injuries 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 has a kink in the body of the guidewire located approximately at 39cm from the distal tip.The surface of the device was carefully inspected and no abnormalities were observed, it was smooth and uniform.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11773974
• Report Number: 2134265-2021-05360
• Device Sequence Number: 11762027
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: 08714729471103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 03/11/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025343970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 70