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

Model Number	29460
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating peeled off.The target lesion was located in the severely tortuous hepatic artery.Three 135/20 renegade hi-flo kit were selected for use.During procedure, it was noted that the coating of the guidewire peeled off.Another two microcatheter of the same batch were unpacked but the same problem occurred.The device was simply pulled out and there were no fragments left inside the patient's body.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The hub, shaft and tip were microscopically examined.The device showed stretching located at 2cm from the hub.Analysis showed 3 kinks located 17.5cm, 45cm and 58cm from the hub.Microscopic analysis of the shaft surface showed no coating issues that were reported.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 the coating peeled off.The target lesion was located in the severely tortuous hepatic artery.Three 135/20 renegade hi-flo kit were selected for use.During procedure, it was noted that the coating of the guidewire peeled off.Another two microcatheter of the same batch were unpacked but the same problem occurred.The device was simply pulled out and there were no fragments left inside the patient's body.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.

• Brand Name: RENEGADE HI-FLO KIT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10791359
• Report Number: 2134265-2020-15196
• Device Sequence Number: 16426077
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: 08714729280781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 06/25/2021
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0024170311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 75