MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 SOFT 205CM; CARDIAC/PERIPHERAL VASCULAR CATHETER GUIDEWIRE, SINGLE-USE

Model Number	M001468060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported during an intra-arterial thrombectomy (iat) procedure the tip of the subject guidewire was broken off in the carotid siphon.The broken fragment of the subject guidewire was attempted to be removed with a snare device but was unsuccessful.Aspiration with a catheter was also attempted to remove the broken fragment but was also unsuccessful.The subject guidewire tip migrated to the m1 segment and was left in the patient.There was a surgical delay of unknown time, and the procedure was not completed.No other information is available.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.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.The device was returned and the lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the subject guidewire distal tip was broken/fractured 204.5 cm from the proximal end and the surface of the break was rough.The distal end was kinked/bent 198cm from the proximal end.Functional testing was not performed due to the condition of the 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 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.Product analysis found the subject guidewire distal tip was broken/fractured 204.5 cm from the proximal end, approximately 0.5cm was not returned.The distal end was kinked/bent 198cm from the proximal end.The condition of the returned subject guidewire suggests that excessive torque and manipulation during the procedure resulted in the observed damage.An assignable cause of procedural factors will be assigned to as reported and as analyzed damage of the guidewire distal tip broken/fractured during use and un-retrieved device fragments and as analyzed damage of the guidewire distal tip broken/fractured during use in addition to the as analyzed damage of the guidewire distal end/tip 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.
Event or Problem Description
It was reported during an intra-arterial thrombectomy (iat) procedure the tip of the subject guidewire was broken off in the carotid siphon.The broken fragment of the subject guidewire was attempted to be removed with a snare device but was unsuccessful.Aspiration with a catheter was also attempted to remove the broken fragment but was also unsuccessful.The subject guidewire tip migrated to the m1 segment and was left in the patient.There was a surgical delay of unknown time, and the procedure was not completed.No other information is available.

• Brand Name: TRANSEND EX 14 SOFT 205CM
• Common Device Name: CARDIAC/PERIPHERAL VASCULAR CATHETER GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16550042
• Report Number: 3008853977-2023-00005
• Device Sequence Number: 6007706
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER (UNKNOWN); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown