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

Model Number	81715
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the liver.An 18x165 cm transend guidewire was selected for use.During insertion, the connection between the hand-held end of the micro guidewire and the main body of the guidewire was fractured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported.The patient status was stable.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the liver.An 18x165 cm transend guidewire was selected for use.During insertion, the connection between the hand-held end of the micro guidewire and the main body of the guidewire was fractured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries reported.The patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire and a torque device were returned for this complaint, and it was observed that the distal tip of the guidewire was bent/kinked.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16029462
• Report Number: 2124215-2022-54208
• Device Sequence Number: 17550197
• Product Code: DQX
• UDI-Device Identifier: 08714729326304
• UDI-Public: 08714729326304
• 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
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 81715
• Device Catalogue Number: 81715
• Device Lot Number: 0028755947
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 52 KG