MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUNWAY; CATHETER, PERCUTANEOUS

Model Number	8575
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/03/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient death occurred.A runway guide catheter was selected for use.During the procedure, when the catheter was being torqued to engage the coronary artery, the catheter became twisted.An attempt was made to pass a wire, but it was unsuccessful.After several more attempts, the physician pulled the knotted guide catheter along with the sheath through the arteriotomy, but the hub of the catheter became detached, leaving the rest of the guide inside the patient.After an attempt to snare the catheter failed, the patient was sent to computerized tomography (ct) where they passed away due to retroperitoneal bleed.
Event or Problem Description
It was reported that patient death occurred.A runway guide catheter was selected for use.During the procedure, when the catheter was being torqued to engage the coronary artery, the catheter became twisted.An attempt was made to pass a wire, but it was unsuccessful.After several more attempts, the physician pulled the knotted guide catheter along with the sheath through the arteriotomy, but the hub of the catheter became detached, leaving the rest of the guide inside the patient.After an attempt to snare the catheter failed, the patient was sent to computerized tomography (ct) where they passed away due to retroperitoneal bleed.It was further reported via medwatch 5114879 that during the urgent cath lab procedure, resistance was met when attempting to inject contrast.
Additional Manufacturer Narrative
The device was returned for analysis along with an introducer sheath.Visual and microscopic observation of the runway device was performed at the catheter hub, shaft, and distal tip.The catheter hub was identified to have been completely separated from the proximal shaft end.The proximal end of the shaft was identified to have been damaged; however, the proximal shaft exhibited no damage other than the proximal end.Shaft kinks were identified 22 cm to 22.5 cm and 25.5 cm from the proximal end of shaft.Severe kinks and twists were also identified 11.6 cm to 16.1 cm from the distal curve and the distal curve was also identified with severe twists.The distal tip was identified separated from the shaft.Visual and microscopic observation of the introducer sheath was performed.The sheath was identified with kinks at the distal end of the sheath and the sheath tip was identified crushed.
Event or Problem Description
It was reported that patient death occurred.A runway guide catheter was selected for use.During the procedure, when the catheter was being torqued to engage the coronary artery, the catheter became twisted.An attempt was made to pass a wire, but it was unsuccessful.After several more attempts, the physician pulled the knotted guide catheter along with the sheath through the arteriotomy, but the hub of the catheter became detached, leaving the rest of the guide inside the patient.After an attempt to snare the catheter failed, the patient was sent to computerized tomography (ct) where they passed away due to retroperitoneal bleed.It was further reported via medwatch 5114879 that during the urgent cath lab procedure, resistance was met when attempting to inject contrast.
Event or Problem Description
It was reported that patient death occurred.A runway guide catheter was selected for use.During the procedure, when the catheter was being torqued to engage the coronary artery, the catheter became twisted.An attempt was made to pass a wire, but it was unsuccessful.After several more attempts, the physician pulled the knotted guide catheter along with the sheath through the arteriotomy, but the hub of the catheter became detached, leaving the rest of the guide inside the patient.After an attempt to snare the catheter failed, the patient was sent to computerized tomography (ct) where they passed away due to retroperitoneal bleed.It was further reported via medwatch 5114879 that during the urgent cath lab procedure, resistance was met when attempting to inject contrast.The device was returned for analysis along with an introducer sheath.Visual and microscopic observation of the runway device was performed at the catheter hub, shaft, and distal tip.The catheter hub was identified to have been completely separated from the proximal shaft end.The proximal end of the shaft was identified to have been damaged; however, the proximal shaft exhibited no damage other than the proximal end.Shaft kinks were identified 22 cm to 22.5 cm and 25.5 cm from the proximal end of shaft.Severe kinks and twists were also identified 11.6 cm to 16.1 cm from the distal curve and the distal curve was also identified with severe twists.The distal tip was identified separated from the shaft.Visual and microscopic observation of the introducer sheath was performed.The sheath was identified with kinks at the distal end of the sheath and the sheath tip was identified crushed.It was further reported via medwatch 5114879 that during the urgent cath lab procedure, resistance was met when attempting to inject contrast.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device analysis findings: the device was returned for analysis along with an introducer sheath.Visual and microscopic observation of the runway device was performed at the catheter hub, shaft, and distal tip.The catheter hub was identified to have been completely separated from the proximal shaft end.The proximal end of the shaft was identified to have been damaged; however, the proximal shaft exhibited no damage other than the proximal end.Shaft kinks were identified 22 cm to 22.5 cm and 25.5 cm from the proximal end of shaft.Severe kinks and twists were also identified 11.6 cm to 16.1 cm from the distal curve and the distal curve was also identified with severe twists.The distal tip was identified separated from the shaft.Visual and microscopic observation of the introducer sheath was performed.The sheath was identified with kinks at the distal end of the sheath and the sheath tip was identified crushed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed and confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation has been assigned the conclusion code adverse event related to procedure.Per the reported event, the device became twisted in attempts to engage the coronary artery and the hub became detached in attempts to remove the device.It is likely that the adverse event of shaft kinks and twists were caused by manipulation of the catheter to position at the coronary artery, and the adverse event of detachment of the hub were likely caused by attempts to remove the guide catheter.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; 6201 america center drive; san jose CA 95002
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16464370
• Report Number: 2124215-2023-09322
• Device Sequence Number: 15096386
• Product Code: DQY
• UDI-Device Identifier: 08714729477884
• UDI-Public: 08714729477884
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023

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 Expiration Date: 04/25/2025
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060363549
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/22/2023; 03/28/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/20/2023; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown