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

Model Number	81735
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The 100% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified upper arm.A 165-cm model-transend guidewire was advanced to cross the thrombotic occlusive lesion.However, during the procedure, the coating on the tip of the wire peeled off.The device was removed without any problem, and the procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned in a generic plastic bag, and overall visual revision did not identify failures or evidence that could be lost due to the decontamination process.As per media inspection, the, physician has provided pictures of the device.In the photos, it can be observed that the guidewire was bent at the distal section and the polymer jacket was detached.As per visual inspection, the device was returned for the analysis, and it is possible to see that the guidewire was bent at the distal section and the polymer jacket was detached.No more damages were detected.The device was put in saline solution, and no reactions were observed on the coating.Under the microscope, there were no observed reactions on the guidewire.Additionally, it is possible to observe the guidewire was bent at the distal section and the polymer jacket was detached.
Event or Problem Description
It was reported that coating issue occurred.The 100% stenosed target lesion was located in a shunt in the moderately tortuous and non-calcified upper arm.A 165-cm model-transend guidewire was selected for use.However, during the procedure, damage occurred, and when a guidewire was advanced to a thrombotic occlusive lesion the coating on the tip of the wire peeled off.The device was removed without any problem using the normal method and the procedure was completed with another of the same devices.No patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17352616
• Report Number: 2124215-2023-35038
• Device Sequence Number: 20356342
• Product Code: DQX
• UDI-Device Identifier: 08714729326281
• UDI-Public: 08714729326281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 02/27/2025
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0031137277
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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 Sex: Unknown