MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND .014 FLOPPY 300 CM ( IC 300 ); WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
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 the procedure, the guidewire(subject device) was advanced with a balloon catheter to lesion at the mca (middle cerebral artery).Once the position was reached, the guidewire distal tip had fractured and the fractured part was removed from the patient.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Product was unable to be analyzed; therefore, the reported event was unable to be confirmed.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.As per the additional information, the device was confirmed to be in good condition during preparation/prior to use on the patient and the device was prepared as per the dfu, the patients anatomy was moderately tortuous.The device was not analyzed therefore the reported event could not be confirmed.It is probable that the device was damaged during advancement through the patients anatomy causing the reported event.An assignable cause of procedural factors will be assigned to the reported ¿guidewire distal tip broken/fractured during use¿ 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 that during the procedure, the guidewire(subject device) was advanced with a balloon catheter to lesion at the mca ( middle cerebral artery).Once the position was reached, the guidewire distal tip had fractured and the fractured part was removed from the patient.The physician replaced it with a new guidewire and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSEND .014 FLOPPY 300 CM ( IC 300 )
• 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: 9572161
• Report Number: 3008853977-2020-00002
• Device Sequence Number: 10839410
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K022357
• 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): 03/31/2020

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: 08/21/2020
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 22550878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR