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 tip detachment occurred and remained inside the patient.The target lesion was in the coronary artery.A moderate support 185cm j-tip pt2 guidewire was used for treatment.During the procedure, entrapment occurred when removing the device.Blood flow was not compromised.The guidewire tip fractured and left inside the patient's body.There were no patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred and remained inside the patient.The target lesion was in the coronary artery.A moderate support 185cm j-tip pt2 guidewire was used for treatment.During the procedure, entrapment occurred when removing the device.Blood flow was not compromised.The guidewire tip fractured and left inside the patient's body.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned for analysis.The distal tip of the guidewire was bent.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 72.1 inches from the proximal end.

• 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: 9452902
• Report Number: 2134265-2019-15539
• Device Sequence Number: 16795851
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 04/10/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0023632342
• 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: 10/01/2020
• 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