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	12/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire's tip detached and the device's tip was left inside the patient.A 185cm light support straight tip pt2 guidewire was selected for use, it was noted that the tip if the guidewire separated and is located in the septal branch.Removal of the fractured tip was not attempted as this would purpose risk to the patient, the physician determined that the fractured tip to be unreachable.The patient was brought back the following day and was doing fine.The patient's om2 vessel remains patent.
Additional Manufacturer Narrative
The unit returned has tip bent, as part of overall visual revision.The device has the distal tip bent and broken, only 183,2 cm were back and the overall should be 185 cm.
Event or Problem Description
It was reported that the wire's tip detached and the device's tip was left inside the patient.A 185cm light support straight tip pt2 guidewire was selected for use, it was noted that the tip if the guidewire separated and is located in the septal branch.Removal of the fractured tip was not attempted as this would purpose risk to the patient, the physician determined that the fractured tip to be unreachable.The patient was brought back the following day and was doing fine.The patient's om2 vessel remains patent.

• 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: 8227618
• Report Number: 2134265-2018-64907
• Device Sequence Number: 2027444
• Product Code: DQX
• UDI-Device Identifier: 08714729471110
• UDI-Public: 08714729471110
• Combination Product (Y/N): N
• 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): 03/27/2019

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: 05/18/2020
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0022141305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/27/2019
• 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: Other