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

Catalog Number	M001468060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the subject guidewire was positioned in the cerebral vasculature.The subject guidewire did not generate distal torque, so an attempt was made to remove it, but it got stuck in the vessel.As a result, the entire system had to be removed, and the access route was lost to prevent the guidewire from migrating.The floppy portion of the subject guidewire got detached.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure the subject guidewire was positioned in the cerebral vasculature.The subject guidewire did not generate distal torque, so an attempt was made to remove it, but it got stuck in the vessel.As a result, the entire system had to be removed, and the access route was lost to prevent the guidewire from migrating.The floppy portion of the subject guidewire got detached.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 inspection the guidewire was seen to be broken/fractured 202cm from the proximal end.No other anomalies were noted.Functional inspection could not be performed as the guidewire was broken/fractured.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 of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the guidewire inside the microcatheter rotated without issue, however, when withdrawn, it also fails to move.On retracting the access system, the guidewire was observed to have come loose along the entire floppy section.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/prior to use on the patient.The continuous flush was set up and maintained throughout the clinical procedure.Further information mentioned that the guidewire did not generate distal torque, so an attempt was made to remove however, the guidewire got stuck in the vessel.No torque was issue observed.The device was returned for analysis, and it was noted that the guidewire was seen to be broken/fractured 202 cm from the proximal end.No other anomalies were noted.The functional inspection could not be performed as the guidewire was broken/fractured.The reported event ¿guidewire difficult to remove/withdraw from catheter¿ could not be duplicated, however, the analysis results are consistent with the reported event and will be assigned a probable cause of procedural factors.The reported and analyzed event: ¿guidewire broken/fractured during use¿ will be assigned a probable cause of procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• 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 ; 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: 20181239
• Report Number: 3008853977-2024-00028
• Device Sequence Number: 20881979
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: (01)08714729201212(17)251123(10)32921171
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 11/13/2024

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: 11/23/2025
• Device Catalogue Number: M001468060
• Device Lot Number: 32921171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Male