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

Model Number	2000
Medical Device Problem Codes	Difficult to Remove (1528); 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 floppy 182cm j choice 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.: the device was returned inside of a protective hoop and together with its original opened cardboard box.A section of the proximal end of the guidewire protruded from the protective hoop and this section showed a kink.The guidewire was easily removed from the protective hoop.The guidewire was inspected and the distal tip was found stretched; the bent observed in the distal tip is expected, due to this device was manufactured as a j tip guidewire.The guidewire body was kinked approximately at 0.2 inches from the proximal end.No more visual damages were found in the device.Microscopic inspection revealed that the distal tip of the guidewire was inspected and it was possible to observe that the spring was stretched.The guidewire was complete and no detached sections were observed.Dimensional inspection revealed that the overall length and distal tip outer diameter (od) were not within specifications due to the stretched spring tip.The middle section od and the proximal section od were within specifications.
Event or Problem Description
It was reported that detachment of device occurred.The target lesion was located in the coronary artery.A floppy 182cm j choice 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: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9450499
• Report Number: 2134265-2019-15459
• Device Sequence Number: 3080510
• Product Code: DQX
• UDI-Device Identifier: 08714729252351
• UDI-Public: 08714729252351
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K143587
• 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): 09/29/2020

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: 03/10/2021
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0023469841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 09/29/2020
• 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: Required Intervention