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

Model Number	29420
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a renegade microcatheter.Analysis of the hub, strain relief, inner and outer shaft involved microscopically and visual inspection.Inspection revealed a complete separation of the outer shaft located 41 cm from the strain relief, the inner shaft was stretched for 16cm, and a shaft kink located 23.4cm from the strain relief.Inspection of the rest of the device found no other damage or irregularities.
Event or Problem Description
Reportable on analysis completed on 23august2019.It was reported that removal difficulties from the carrier tube occurred.During preparation of a 105/20 renegade hi-flo catheter, the catheter was difficult to remove from the carrier tube.The carrier tube was flushed again and attempts to remove the catheter resulted in stretching the catheter when it was finally released from the carrier tube.However returned analysis revealed a detached shaft.

• 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: 9035803
• Report Number: 2134265-2019-11197
• Device Sequence Number: 14001384
• Product Code: KRA
• UDI-Device Identifier: 08714729280606
• UDI-Public: 08714729280606
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: 03/24/2022
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0023688915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1