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

Model Number	8575
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter broke, requiring surgery for removal.The target lesion was located in the femoral artery.A 6f runway cls4 guide catheter was selected for use.During the procedure, the cardiac catheter broke off while in the patient.The hub of the catheter broke and the catheter had significant kinks.Patient was transferred to hospital with vascular surgery capabilities since catheter was unable to be retrieved in cardiovascular lab.Femoral artery was cutdown and catheter retrieval was completed without further incident.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10521226
• Report Number: 2134265-2020-12637
• Device Sequence Number: 16908105
• Product Code: DQY
• UDI-Device Identifier: 08714729478393
• UDI-Public: 08714729478393
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 02/06/2023
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060225922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention