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

Model Number	81735
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the middle cerebral artery.The first guidewire with hydrophilic coating was used for accessing the lesion but guidewire fatigue occurred.A.014/190cm transend guidewire was advanced during the procedure; however, the guidewire fractured in the lesion and could not be retrieved.The physician used another guidewire to access the occlusion but failed despite multiple attempts.The procedure was not completed due to this event.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was returned, and it is possible to see that the guidewire was bent at the proximal section and detached at the distal tip.No more damages were detected.Under the microscope it was observed the distal tip of the guidewire detached.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the middle cerebral artery.The first guidewire with hydrophilic coating was used for accessing the lesion but guidewire fatigue occurred.A.014/190cm transend guidewire was advanced during the procedure; however, the guidewire fractured in the lesion and could not be retrieved.The physician used another guidewire to access the occlusion but failed despite multiple attempts.The procedure was not completed due to this event.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).E1 - initial reporter address: updated.H6 - device code: corrected.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the middle cerebral artery.The first guidewire with hydrophilic coating was used for accessing the lesion but guidewire fatigue occurred.A.014/190cm transcend guidewire was advanced during the procedure; however, the guidewire fractured in the lesion and could not be retrieved.The physician used another guidewire to access the occlusion but failed despite multiple attempts.The procedure was not completed due to this event.There were no patient complications reported and the patient condition was stable.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16885954
• Report Number: 2124215-2023-21004
• Device Sequence Number: 6141480
• Product Code: DQX
• UDI-Device Identifier: 08714729326243
• UDI-Public: 08714729326243
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2023

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: 11/07/2024
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0030506502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/08/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/01/2023; 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male