MAUDE Adverse Event Report: TRANSEND; WIRE, GUIDE, CATHETER

Model Number	81715
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred.An 18 165cm model transend guidewire was unpacked and opened, however, it was noted that it was detached in two pieces.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
D9.Returned to manufacturer date was updated.Device evaluation by mfr: unit returned with its original pouch batch (b)(6), 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 very tip in good conditions.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.
Event or Problem Description
It was reported that guidewire detachment occurred.An 18 165cm model transcend guidewire was unpacked and opened, however, it was noted that it was detached in two pieces.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12553656
• Report Number: 2134265-2021-11644
• Device Sequence Number: 983180
• Product Code: DQX
• UDI-Device Identifier: 08714729326304
• UDI-Public: 08714729326304
• 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): 10/26/2021

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: 03/26/2023
• Device Model Number: 81715
• Device Catalogue Number: 81715
• Device Lot Number: 0027043803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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: 39 YR
• Patient Weight: 65