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

Model Number	2777
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the circumflex artery.A 185cm moderate support straight pt2 guidewire was selected for use.However, during the procedure, the tip of the wire was fractured.It was noted that the location of the fracture was not where the tip was shaped.The fractured tip migrated to small distal branch.Physician did not attempt to snare the detached wire as it was safer for the patient to leave the tip.The procedure was completed and there were no further patient complications reported.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the circumflex artery.A 185cm moderate support straight pt2 guidewire was selected for use.However, during the procedure, the tip of the wire was fractured.It was noted that the location of the fracture was not where the tip was shaped.The fractured tip migrated to small distal branch.Physician did not attempt to snare the detached wire as it was safer for the patient to leave the tip.The procedure was completed and there were no further patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: pt 185cm moderate support straight was return for analysis.The unit returned has the tip kinked, as part of overall visual revision.The guidewire polymer tip was found fractured, approximately at 183.3 cm from the proximal end, the detached section was not returned.Besides, the distal tip was bent approximately at 182 cm from the proximal end.No more damages were found.The outer diameter of middle of the device and proximal section are within specifications.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the circumflex artery.A 185cm moderate support straight pt2 guidewire was selected for use.However, during the procedure, the tip of the wire was fractured.It was noted that the location of the fracture was not where the tip was shaped.The fractured tip migrated to small distal branch.Physician did not attempt to snare the detached wire as it was safer for the patient to leave the tip.The procedure was completed and there were no further patient complications 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: 9195191
• Report Number: 2134265-2019-12393
• Device Sequence Number: 2054697
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 06/26/2021
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0024023599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 11/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/31/2019; 12/02/2019
• 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: 65 YR