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

Model Number	8575
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: return product consisted of a runway guide catheter and loose fm.Analysis of the tip, shaft and hub included microscopic and visual inspection.Inspection found no damage to the device.The returned foreign matter (fm) was tangled together and could not be measured accurately.The fm was identified as fluorocarbon fiber, which is consistent with ptfe lining.
Event or Problem Description
It was reported that foreign matter was present on the device.A model 6f runway jl3.5 guide catheter was selected for use in a percutaneous coronary intervention (pci).During the procedure, when the physician inserted the guide catheter, there was a string like a nylon coming out of the guide catheter.The physician quickly pulled the guide catheter out from the radial.The procedure was completed with a different device.No patient complications were reported and the patient was stable post procedure.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9929439
• Report Number: 2134265-2020-04348
• Device Sequence Number: 19005383
• Product Code: DQY
• UDI-Device Identifier: 08714729478713
• UDI-Public: 08714729478713
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: 12/12/2020
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060102873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR