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

Model Number	29420
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a renegade hi-flo microcatheter.Analysis of the tip, inner/outer shaft and the hub/strain relief included microscopic and visual inspection.Inspection revealed the inner and outer shaft was damaged (stretched) for 22mm that started at the strain relief, and the outer shaft separated at 32cm from the strain relief with the inner shaft damaged (stretched) between the fracture.Inspection of the remainder of the device, apart from the damage observed revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 28 oct 2019.It was reported that the catheter had lumen issue.The target lesion was located in bronchial artery.A 135/20 renegade hi-flo was selected for use.During the procedure, it was noted that the catheter lumen had issues.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.However, device analysis revealed that the outer shaft separated at 32cm from the strain relief.

• 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: 9335038
• Report Number: 2134265-2019-13900
• Device Sequence Number: 1872969
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140329
• 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
• Report Date (Section B): 11/18/2019

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: 05/22/2020
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0020800045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR