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

Model Number	81735
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified bronchial artery.A.014/190cm gw transend periph guidewire was advanced into the lesion; however, during the procedure, the wire tip was broken.The broken wire tip could not be removed due to difficulties in the procedure.The procedure was completed with another of same device.No complications were reported and the patient was fine.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified bronchial artery.A.014/190cm gw transend periph guidewire was advanced into the lesion; however, during the procedure, the wire tip was broken.The broken wire tip could not be removed due to difficulties in the procedure.The procedure was completed with another of same device.No complications were reported and the patient was fine.
Additional Manufacturer Narrative
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 returned device matches with upn and lot provided by the customer.The device was inspected and no issues or detachment sections were identified.No other issues were observed in the device.Under microscope it was possible to observed the polymer very tip detached.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12026328
• Report Number: 2134265-2021-07660
• Device Sequence Number: 16487616
• Product Code: DQX
• UDI-Device Identifier: 08714729326243
• UDI-Public: 08714729326243
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: 03/20/2023
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0026976506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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: 75 YR