MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation the operator found one small part of the guidewire (subject device) was separated from the tip of the guidewire (subject device).The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The device was returned for analysis and it was discovered that the guidewire (subject device) ptfe (polytetrafluoroethylene) was noted to be peeled.No clinical consequences were reported to the patient due to this event.
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 inspection, the guidewire was noted to be kinked/bent at 286cm from the proximal end, the guidewire ptfe was noted to be peeled in multiple areas to 170cm from the proximal, and the core wire was noted to be broken.A functional test was not required.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 reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that after shaping the guidewire to a j shape with the shaping needle, the operator found one small part of the wire was separated from the tip, so the guidewire was replaced with another one to continue the procedure.Additional information provided by the customer indicated that no damage was noted to the packaging prior to opening the packaging and the device was prepared as per the dfu.During analysis, the guidewire was noted to be kinked/bent at 286cm from the proximal end, the ptfe coating was noted to be peeled in multiple areas up to 170cm from the proximal end, and the core wire was noted to be broken.Based on the analysis and information provided, an assignable cause of handling damage will be assigned to the as reported / as analyzed 'guidewire distal tip broken/fractured during preparation' as well as the as analyzed 'guidewire kinked/bent' and 'guidewire ptfe coating peeling' since these defects appear to be associated with handling of the product upon removal of the product from the packaging or preparation of the product prior to use.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• 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: 15126854
• Report Number: 3008853977-2022-00040
• Device Sequence Number: 6603645
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022357
• 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): 07/28/2022

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: 09/08/2023
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 27982606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Race: Asian