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

Model Number	M001468060
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, the guidewire was kinked at 12cm from the distal and at 26cm from the proximal end.There was some slight damage and peeling noted to the ptfe coating at 34cm from the proximal end which is indicative of torque device damage.During functional inspection, the guidewire was hydrated and there were no anomalies noted when wet fingers were run along its length.An attempt was made to advance the guidewire through the returned balloon catheters; however, this was not possible for one of the balloon catheters due to solidified contrast media blocking its shaft.The guidewire passed to the distal tip of the other balloon catheter without difficulty once the solidified contrast was removed from the inner lumen.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 not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation.It is probable that the viscous contrast and blood found within the balloons may have caused the reported event and the damage noted to the guidewire, therefore an assignable cause of procedural factors will be assigned to the reported device interaction with another device and the guidewire kinked/bent, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.It is probable that the ptfe coating was damaged by the torque device during manipulation of the device, therefore an assignable cause of handling damage will be assigned to the analyzed guidewire ptfe coating peeling.
Event or Problem Description
The guidewire (subject device) was returned for analysis and it was discovered that there was some slight damage and peeling noted to the ptfe coating at the proximal end due to a torque device used during manipulation of the device.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSEND EX 14 SOFT 205CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CR 20101
• MDR Report Key: 10247737
• Report Number: 3008853977-2020-00022
• Device Sequence Number: 594999
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K931584
• 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): 07/08/2020

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: 09/18/2021
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: 24461413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1