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

Model Number	2777
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire tip fracture occurred.The chronic totally occluded target lesion was located in a mildly tortuous and severely calcified vessel.A 185 cm moderate support straight pt guidewire was selected for use.However, at the end of the procedure, the tip of the guidewire fractured off inside the patient.The fractured tip was successfully snared.No further complications were 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 guidewire was found broken/fractured; the damaged area was located in the distal tip, approximately at 184.5 cm from the proximal end, the detached section was not returned.Besides, the distal tip was bent.No more damages were found.Overall length and outer diameter (od) could not be performed due to device condition (guidewire broken/fractured).Od of middle of the device and proximal section are within specification.
Event or Problem Description
It was reported that a guidewire tip fracture occurred.The chronic totally occluded target lesion was located in a mildly tortuous and severely calcified vessel.A 185cm moderate support straight pt guidewire was selected for use.However, at the end of the procedure, the tip of the guidewire fractured off inside the patient.The fractured tip was successfully snared.No further complications were reported.

• 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: 9171708
• Report Number: 2134265-2019-12183
• Device Sequence Number: 16848888
• Product Code: DQX
• UDI-Device Identifier: 08714729471196
• UDI-Public: 08714729471196
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 05/22/2021
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0023839012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR