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

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the left anterior descending artery.A 185 cm pt2 guidewire was used in a procedure.However, the tip of the wire broke off.The detached tip was stented over to secure it.No patient complications were reported.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the left anterior descending artery.A 185cm pt2 guidewire was used in a procedure.However, the tip of the wire broke off.The detached tip was stented over to secure it.No patient complications were reported.It was further reported via a med watch report that while the wire was in the vessel that it folded back on itself.Post stenting, physician tried to pulled the wire out but the end of the wire became lodged in the stent strut.The physician tried to used multiple devices to get the wire but was not able to.The wire was able to be pulled back partially and straightened out.But in the attempt to get it unstuck the distal end of the wire broke off.The patient was left with a small portion of the wire in her stent struts.
Additional Manufacturer Narrative
Patient weight, race, ethnicity and initial reporter updated via user/facility medwatch# (b)(4).

• 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: 8650270
• Report Number: 2134265-2019-05968
• Device Sequence Number: 16689918
• Product Code: DQX
• UDI-Device Identifier: 08714729471219
• UDI-Public: 08714729471219
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/23/2019

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: 03/08/2021
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0023462601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 59 YR
• Patient Weight: 76