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

Model Number	8575
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified artery.A 6f runway guide catheter was selected for use.However, when the guiding catheter was tried to insert during acute myocardial infarction case, it was noted that the second curve got kinked/broken.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Mfr site address 2: no.20905 int.A.Col.,cd.Industrial, 22444.Device evaluated by mfr.: returned product consisted of a runway guide catheter.The device showed 1 kink.The kink was located at the strain relief.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified artery.A 6f runway guide catheter was selected for use.However, when the guiding catheter was tried to insert during acute myocardial infarction case, it was noted that the second curve got kinked/broken.The procedure was completed with another of the same 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: 7981048
• Report Number: 2134265-2018-62061
• Device Sequence Number: 13811685
• Product Code: DQY
• UDI-Device Identifier: 08714729478386
• UDI-Public: 08714729478386
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/16/2019

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: 04/26/2021
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060122686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1