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

Model Number	2779
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the mid right coronary artery.A 185cm pt2 guide wire was used in a procedure.However, it was noticed that tip was fractured when the physician adjusted the guide wire.The fractured part was left inside patient's body and the physician rescheduled the procedure to retrieve the fragment.No further patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
A4 - weight: 72.5 kgs.Device evaluated by mfr.: the device was returned for analysis.The distal tip of the guidewire was bent.No more visual damages were encountered.During this inspection the polymer jacket coating of the guidewire was carefully inspected a section of it was detached and it was not returned; this damage was located approximately at 72.5 inches from the proximal end.The outer dimension of the middle section and proximal section were within specification.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the middle right coronary artery.A 185cm pt2 guidewire was used for treatment.However, it was noticed that tip of the guidewire was fractured when adjusted.Fractured part was still left inside patient's body.Physician rescheduled the procedure to retrieved the fragments left inside the patient's body.As of now, there were no patient complications nor injuries reported and the patient's status was stable.It was further reported the lesion was severely stenosed with mild calcification and mild tortuosity.
Additional Manufacturer Narrative
Correction: h6 evaluation conclusion codes.Initially reported adverse event related to procedure corrected to adverse event related to patient condition.A4: weight: 72.5 kgs.Device evaluated by mfr.: the device was returned for analysis.The distal tip of the guidewire was bent.No more visual damages were encountered.During this inspection the polymer jacket coating of the guidewire was carefully inspected a section of it was detached and it was not returned; this damage was located approximately at 72.5 inches from the proximal end.The outer dimension of the middle section and proximal section were within specification.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the mid right coronary artery.A 185cm pt2 guide wire was used in a procedure.However, it was noticed that tip was fractured when the physician adjusted the guide wire.The fractured part was left inside patient's body and the physician rescheduled the procedure to retrieve the fragment.No further patient complications were reported and the patient's status was stable.It was further reported the lesion was severely stenosed with mild calcification and mild tortuosity.

• 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: 10560637
• Report Number: 2134265-2020-12995
• Device Sequence Number: 2627782
• Product Code: DQX
• UDI-Device Identifier: 08714729471189
• UDI-Public: 08714729471189
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

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: 03/06/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0023452709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 02/19/2021
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/09/2020; 02/19/2021
• 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
• Patient Age: 57 YR