MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 182CM; WIRE, GUIDE, CATHETER

Model Number	M001468050
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual/microscopic inspection, the guidewire was seen to be kinked/bent at 54cm and 58cm from the proximal end.The guidewire ptfe coating was seen to be peeling at 29cm from the proximal end.During functional inspection, the guidewire was hydrated and advanced into a demonstration microcatheter.It took over 20 rotations to tighten up the torque device.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the torque device did not tighten enough to facilitate the directional manipulation and movement of the subject guidewire.Additional information provided by the customer indicated that no damage was noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per the dfu, the introducer was used with the guidewire during the insertion process, and the issue was noted during the procedure when pressing the torquer on the guidewire.During analysis, the guidewire was seen to be kinked/bent at 54cm and 58cm from the proximal end.The guidewire ptfe coating was also seen to be peeling at 29cm from the proximal end.Based upon visual inspection, the ptfe coating damage most likely occurred as a result of interaction with another device.The damage noted is consistent with insecure fastening of the torque device which can cause drag marks on the wire from the torque device collet.An assignable cause of handling damage will be assigned to the as analyzed defects guidewire kinked/bent' and ¿guidewire ptfe coating peeling' since these issues are associated with handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.During functional testing, it took over 20 rotations to tighten up the torque device on the wire.Therefore, the reported event was confirmed.Based on the analysis from the previously returned units, it was concluded that the device can still be used without damaging the guidewire, even when friction is present and if experiencing friction when tightening the torquer device over the guidewire, continue to tighten past initial friction until the guidewire is securely fastened (when there is no slippage).An assignable cause of 'user preference issue' will be assigned to the as reported defect ¿guidewire torque problem' as this is an issue in which the product meets specification however the user is dissatisfied with the function, performance, or appearance of the product.
Event or Problem Description
Analysis of the returned device found that the ptfe coating of the subject guidewire was peeled.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: TRANSEND EX 14 182CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16781676
• Report Number: 3008853977-2023-00012
• Device Sequence Number: 6986926
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K971254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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: 05/29/2023
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 27404380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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 Sex: Unknown