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

Model Number	M001468110
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 20nov2024.It was reported that the tip of the wire was asymmetrical, and not straight.A 165cm transend guidewire was selected for use.When the package was opened, the tip was found asymmetrical, and not straight.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.However, returned device analysis revealed that the proximal polymer jacket was peeled.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.Visual inspection observed that the proximal polymer jacket was peeled and bent at the distal tip.Based on the evidence, the reported allegation of damage tip was confirmed, since the kink and peeled was found during the product inspection that could have contributed to the reported issue.

• 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: 20866834
• Report Number: 2124215-2024-76180
• Device Sequence Number: 12905106
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 02/08/2026
• Device Model Number: M001468110
• Device Catalogue Number: M001468110
• Device Lot Number: 0033394776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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: Male