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

Model Number	81735
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient underwent transarterial chemoembolization (tace).The target lesion was located in the liver.A 165cm transend guidewire was used to cross the lesion.However, the guidewire was stuck inside the catheter while advancing and could not be delivered into the patient.There was also difficulty removing the guidewire from the catheter.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable.
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient underwent transarterial chemoembolization (tace).The target lesion was located in the liver.A 165cm transend guidewire was used to cross the lesion.However, the guidewire was stuck inside the catheter while advancing and could not be delivered into the patient.There was also difficulty removing the guidewire from the catheter.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.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 inspected and was found bent in the distal end.No other issues were observed in the device.The device was inspected microscopically and was observed the distal end bent.The device was measured in three sections (distal - medium - proximal) and were within specification.The device was test by using the activation coating, the distal end was soaked in saline solution in order to check the distal tip and this section was observed without issues or anomalies identified.

• 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: 12247273
• Report Number: 2134265-2021-09680
• Device Sequence Number: 2796131
• Product Code: DQX
• UDI-Device Identifier: 08714729326281
• UDI-Public: 08714729326281
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 02/09/2023
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0026782444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 70