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

Model Number	8575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a mach 1 guide catheter.The batch number on the hub was 60161863.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed tip damage, with the soft portion of the tip was frayed with the braiding exposed.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
Reportable based on device analysis completed on 15oct2020.It was reported that tip damage was observed.A model-6f runway fr4 catheter-guide was selected for use.During the procedure, it was noted that the catheter has tip kneaded.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed the soft portion of the tip was frayed with the braiding exposed.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10801365
• Report Number: 2134265-2020-15468
• Device Sequence Number: 3266954
• Product Code: DQY
• UDI-Device Identifier: 08714729477631
• UDI-Public: 08714729477631
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/06/2020

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: 11/30/2021
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060161863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1