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

Model Number	M001468080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a procedure for a ba (basilar artery) aneurysm case, physician used the first guidewire to work with microcatheter to reach target location.The case was very complicated, and the vertebral artery (va) was very tortuous, so it was difficult to set the first guidewire to the target point.During the delivery of the first guidewire, friction was encountered, and the distal tip fractured at the connection of va and ba.Physician withdrew the first guidewire and used a microcatheter to remove the fractured part.The physician proceeded to use the second subject guidewire, however the same event occurred.The fractured piece was removed through aspiration.The physician replaced it with a new similar device and continued the procedure without clinical consequences to the patient.
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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.It was reported that the subject guidewire tip had fractured within the patient during use.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and a microcatheter was used in conjunction with the subject device.The patient's anatomy was reported to be severely tortuous and due to the tortuous blood vessels the operator tried to the rotate the guidewire to make it pass through the lesion site when the head of the guidewire was broken.Based on the information provided, it is likely that severe tortuosity in the vertebral arteries (va) caused difficulties during advancement of the guidewire and excessive force against resistance may have resulted in separation of the guidewire tip.An assignable cause of procedural factors will be assigned to the as reported 'guidewire distal tip broken/fractured during use' and 'guidewire friction' since these issues appear 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 and/or anatomical factors during use.
Event or Problem Description
It was reported that during a procedure for a ba (basilar artery) aneurysm case, physician used the first guidewire to work with microcatheter to reach target location.The case was very complicated, and the vertebral artery (va) was very tortuous, so it was difficult to set the first guidewire to the target point.During the delivery of the first guidewire, friction was encountered, and the distal tip fractured at the connection of va and ba.Physician withdrew the first guidewire and used a microcatheter to remove the fractured part.The physician proceeded to use the second subject guidewire, however the same event occurred.The fractured piece was removed through aspiration.The physician replaced it with a new similar device and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSEND EX 14 PLATINUM 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
• MDR Report Key: 11060789
• Report Number: 3008853977-2020-00039
• Device Sequence Number: 2876591
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/08/2021

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: 09/23/2021
• Device Model Number: M001468080
• Device Catalogue Number: M001468080
• Device Lot Number: 24486519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GUIDEWIRE (UNKNOWN); TRANSEND EX 14 GUIDEWIRE (STRYKER)
• Patient Age: 62 YR