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

Model Number	8575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date was not reported and was approximated to (b)(6) 2020.
Event or Problem Description
It was reported that catheter break occurred.The target vessel was located in coronary artery.A runway guide catheter was selected for coronary angioplasty.During preparation, the guide catheter broke.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that catheter break occurred.The target vessel was located in coronary artery.A runway guide catheter was selected for coronary angioplasty.During preparation, the guide catheter broke.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: event date was not reported and was approximated to (b)(6) 2020.Device evaluated by mfr: return product consisted of a runway guide catheter.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed a kink in the shaft located 16mm from the tip of the device.Inspection of the rest of the device found no other damage or defect with the returned device.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11123931
• Report Number: 2134265-2020-18769
• Device Sequence Number: 11753820
• Product Code: DQY
• UDI-Device Identifier: 08714729478386
• UDI-Public: 08714729478386
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 06/26/2023
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060247542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1