MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Model Number	M003468150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the guidewire (subject device) was stuck inside the posterior communicating artery (pca) when the physician attempted to remove the subject guidewire.The physician made several attempts to remove the subject guidewire but was not successful.The physician had to cut the subject guidewire at the groin and leave it behind in the patient's anatomy.The physician indicated that the guidewire was possibly advanced into a small pca side branch rather than the larger parent trunk as expected.A small volume of subarachnoid hemorrhage was noted in patient around the distal end of the subject guidewire post procedure.It was reported that the patient has been made palliative.
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 subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, and continuous flush was maintained throughout the clinical procedure.According to the physician, the wire became firmly stuck in the patient's left pca (posterior communicating artery) territory.The wire was possibly advanced into a small pca side branch rather than the larger parent trunk as expected.The guide wire was cut at the groin with a wire cutter and had to be left behind in the patient.The un-retrieved fragment was not removed from the patient's anatomy and a small volume subarachnoid hemorrhage was noted around the distal end of the wire post op.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that the guidewire (subject device) was stuck inside the posterior communicating artery (pca) when the physician attempted to remove the subject guidewire.The physician made several attempts to remove the subject guidewire but was not successful.The physician had to cut the subject guidewire at the groin and leave it behind in the patient's anatomy.The physician indicated that the guidewire was possibly advanced into a small pca side branch rather than the larger parent trunk as expected.A small volume of subarachnoid hemorrhage was noted in patient around the distal end of the subject guidewire post procedure.It was reported that the patient has been made palliative.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• 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: 11298368
• Report Number: 3008853977-2021-00004
• Device Sequence Number: 3478862
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: 08714729441748
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: M003468150
• Device Catalogue Number: M003468150
• Device Lot Number: 25435858
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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: WINGSPAN STENT (STRYKER); WIRE CUTTER (UNKNOWN MANUFACTURER); WINGSPAN STENT (STRYKER); WIRE CUTTER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention