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

Model Number	8575
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
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 use.During preparation, when the guide catheter was from the package, it was observed to be broken.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Mfr site address: c.Industrial lt.001 mz.105, no.20905 int.A.Col.,cd.Industrial, 22444.Device evaluated by mfr: the 6f runway guide catheter was returned for evaluation.Analysis of the returned device consisted of the tip and shaft microscopically and visually inspected.Inspection revealed numerous kinks in the sheath.Inspection of the rest of the device found no other damage or irregularities.
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 use.During preparation, when the guide catheter was from the package, it was observed to be broken.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8683462
• Report Number: 2134265-2019-06551
• Device Sequence Number: 2207254
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 03/11/2022
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060175826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1