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

Model Number	2779
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment of device occurred.The target lesion was located in the coronary artery.A pt2 guidewire was used for treatment.However, during procedure, entrapment occurred when removing the device.The guidewire tip fracture remained inside the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original box.The guidewire returned inside of a protective hoop together with its original opened pouch.The guidewire was easily removed from the protective hoop.The distal tip of the guidewire was bent.No more visual damages were encountered.Microscopic inspection revealed 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.A small section of the core wire protruded from the polymer jacket section.Dimensional inspection of the overall length and distal tip outer diameter (od) did not pass specification due to the polymer jacket detached.The middle section od and the proximal section od were within specification.
Event or Problem Description
It was reported that detachment of device occurred.The target lesion was located in the coronary artery.A pt2 guidewire was used for treatment.However, during procedure, entrapment occurred when removing the device.The guidewire tip fracture remained inside the patient's body.

• 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: 9444376
• Report Number: 2134265-2019-15359
• Device Sequence Number: 2055630
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 01/21/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0023228154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 09/24/2020
• 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