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

Model Number	M001468070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation yet.
Event or Problem Description
It was reported that the guidewire (subject device) tip was broken off while inserting into catheter hub.The broken tip was removed from the catheter hub.It was replaced with another and the procedure was completed successfully.There was no clinical consequences to the patient.
Event or Problem Description
It was reported that the guidewire (subject device) tip was broken off while inserting into catheter hub.The broken tip was removed from the catheter hub.It was replaced with another and the procedure was completed successfully.There was no clinical consequences to the patient.
Additional Manufacturer Narrative
A dhr (device history record) review was performed for the lot number implicated in this complaint and no manufacturing issue was found related to the reported event.A visual and microscopic inspection was performed and the guidewire was noted to be broken and kinked at 77cm from the proximal end, confirming the reported event.There was a kink noted at 7cm from the fracture point.The distal end of the guidewire was kinked at 2.5cm from the tip.Functional testing was not required as the defect was visually identified.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.An assignable cause of procedural factors will be assigned to the reported event, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but the product performance was limited due to procedural and/or anatomical factors during use.

• 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 ; CR 20101
• MDR Report Key: 9578672
• Report Number: 3008853977-2020-00003
• Device Sequence Number: 3042896
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/20/2020

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: 03/25/2021
• Device Model Number: M001468070
• Device Catalogue Number: M001468070
• Device Lot Number: 23542965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1