MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number	29420
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip marker fell and remained in the patient's body.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 135/20 renegade hi-flo was selected for use.During the procedure, the tip marker fell off and flowed in the distal coronary artery when the wire was loaded.Consequently, the fragment was pushed/fixed towards the periphery of the vessel.It was thought that it was caught by the y connector when the microcatheter was pulled out.The procedure was completed with another of same device.No further complications were reported, and patient was stable post procedure.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12230257
• Report Number: 2134265-2021-09429
• Device Sequence Number: 14403339
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140329
• 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
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0024849368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other