MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN NEURO RENEGADE HI FLO 150/10; CATHETER, CONTINUOUS FLUSH

Catalog Number	M003182900US0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The catheter was stretched on its proximal shaft.The catheter was examined before decontamination and it was observed that the catheter was jammed in the dispenser coil.The dispenser coil was flushed and the catheter was pulled out of the dispenser coil without any difficulties.Visual and microscopic examination of the returned device found that the catheter was severely stretched on proximal shaft at 12.5 cm distal to strain relief, the catheter outer shaft was separated, and the catheter inner braided shaft was stretched.Per the device dfu, "gently remove the microcatheter from the dispenser coil and inspect the microcatheter prior to use to verify that it is undamaged." the analyzed anomalies are indicative of difficulties removing the catheter from the dispenser hoop.It appears that the catheter was pulled out of the dispenser hoop with force, causing the analyzed anomalies.Therefore, an assignable cause of user error has been assigned to the analyzed anomalies.
Event or Problem Description
Based on the investigation of the returned product, it was found that the catheter shaft was broken.There was no patient involvement.

• Brand Name: NEURO RENEGADE HI FLO 150/10
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6748074
• Report Number: 3008853977-2017-00015
• Device Sequence Number: 19000400
• Product Code: KRA
• UDI-Device Identifier: 08714729767510
• UDI-Public: (01)08714729767510(17)190531(10)19427609
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K000177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 05/31/2019
• Device Catalogue Number: M003182900US0
• Device Lot Number: 19427609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1