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

Model Number	81735
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: unit returned in a generic plastic bag, unit received stuck into a direxion, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire returned inside into a direxion catheter.The guidewire was kinked.The distal tip polymer was detached.The distal end has the polytetrafluoroethylene (ptfe) peeled.No other issues were observed in the device.The guidewire was jammed into a direxion catheter.It was necessary to cut the catheter to pulled out backwards in order to release the guidewire.The outer diameter of distal tip, middle of the device and the proximal section are within specifications.Overall length could not be measured due the distal tip was detached.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
Reportable based on device analysis completed on 20may2022.The target lesion was located in a vessel in the liver.A 165cm transend guidewire was advanced to cross the lesion.However, before entering the patient, the guidewire became stuck in the y valve of the microcatheter and only a portion of the guidewire could be advanced.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed distal tip polymer detached and coating peeled off.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14696635
• Report Number: 2134265-2022-06684
• Device Sequence Number: 5176157
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2022

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: 06/01/2023
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0027417231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG