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

Model Number	8575
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A 2.25 x 20mm synergy drug-eluting stent and 2 model-6f cls3.5 runway guide catheters were used for treatment.Post sedation prior to use, it was noted that the guide catheter did not retain its shape, another device was opened and had the same issue.The stent was advanced multiple times but failed to cross the lesion.The stent was removed and the procedure was not completed.No patient complications were reported and patient was stable.
Event or Problem Description
It was reported that the procedure was cancelled.A 2.25 x 20mm synergy drug-eluting stent and 2 model-6f cls3.5 runway guide catheters were used for treatment.Post sedation prior to use, it was noted that the guide catheter did not retain its shape, another device was opened and had the same issue.The stent was advanced multiple times but failed to cross the lesion.The stent was removed and the procedure was not completed.No patient complications were reported and patient was stable.It was further reported that the physician used a guideliner and managed to treat the patient, and the procedure was completed.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10120284
• Report Number: 2134265-2020-07493
• Device Sequence Number: 16673288
• Product Code: DQY
• UDI-Device Identifier: 08714729478386
• UDI-Public: 08714729478386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/16/2020

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: 12/05/2022
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060218624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR