MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 FLOPPY 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468070
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual/microscopic inspection, an attempt had been made to shape the guidewire tip.The guidewire distal end/tip was noted to be kinked/bent.The guidewire was noted to be kinked/bent at 53cm and 181.5cm from the proximal end.The guidewire ptfe coating was noted to be peeling from 94cm to 137cm from the proximal end.During functional inspection, the coating was hydrated, no anomalies were noted.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 coating debris was found on the subject guidewire during preparation.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 prior to use on the patient and was prepared for use as per the dfu, the issue occurred in the peripheral artery, and the anatomy was not tortuous.During analysis, the guidewire was noted to be kinked/bent at 53cm and 181.5cm from the proximal end, the distal tip was noted to be kinked/bent, and the ptfe coating was noted to be peeled from 94cm to 137cm from the proximal end.No anomalies were noted to the hydrophilic coating when hydrated.It is probable that the guidewire was damaged from handling during preparation.The ptfe coating damage is consistent with backloading the proximal end of the guidewire into the distal end of the insertion tool and pulling it through the insertion tool at an angle.An assignable cause of handling damage will be assigned to the as reported 'guidewire coating issue' and the as analyzed 'guidewire ptfe coating peeling', 'guidewire kinked/bent' and 'guidewire distal end/tip kinked/bent' since these defects 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.
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 FLOPPY 205CM
• 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: 15787121
• Report Number: 3008853977-2022-00054
• Device Sequence Number: 17546872
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K944677
• 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): 11/14/2022

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: 02/04/2023
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 26756331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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