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

Model Number	2779
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire fractured.A 185cm pt guidewire was selected for a percutaneous coronary intervention (pci).During the procedure, the wire became stuck in a stent strut and broke off.Additional intervention was required.There were no additional patient complications reported and the patient fully recovered.The procedure was successfully completed.
Event or Problem Description
It was reported that the guidewire fractured.A 185cm pt guidewire was selected for a percutaneous coronary intervention (pci).During the procedure, the wire became stuck in a stent strut and broke off.Additional intervention was required.There were no additional patient complications reported and the patient fully recovered.The procedure was successfully completed.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned with its original pouch batch 24064101, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matched with upn provided by the customer.A visual inspection was carried out.The guidewire returned together with its original opened pouch.The polymer jacket coating of the guidewire was carefully inspected a section of it was detached; the detached section was not returned.The damaged section was located approximately at 72.18 inches from the proximal end.No more visual damages were encountered.A microscopic inspection was carried out.The detailed pictures of the affected area were captured.A small section of the core wire protruded from the polymer jacket section.It was inspected according to procedure.The device was measured according to drawings.

• 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: 10460328
• Report Number: 2134265-2020-11791
• Device Sequence Number: 19568057
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0024064101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR