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	09/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter broke during unpacking.A 6f runway fl3.5 runway catheter was selected for a coronary angioplasty.When taking the catheter out of its packaging, the catheter body was broken.No patient complications were reported.
Event or Problem Description
It was reported that catheter broke during unpacking.A 6f runway fl3.5 runway catheter was selected for a coronary angioplasty.When taking the catheter out of its packaging, the catheter body was broken.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a runway guide catheter in its opened pouch packaging.Analysis of the tip and sheath included microscopic and visual inspection.Inspection revealed kinks in the shaft located 16cm, 47cm and 48cm from the strain relief.Inspection of the rest of the device found no other damage or defects.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10734208
• Report Number: 2134265-2020-14663
• Device Sequence Number: 1114732
• Product Code: DQY
• UDI-Device Identifier: 08714729477679
• UDI-Public: 08714729477679
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 02/17/2023
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060227804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1