MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN F/G RENEGADE 150/20/2TIP; CATHETER, CONTINUOUS FLUSH

Catalog Number	M001182590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the catheter was stretched on its proximal shaft at 2.5cm distal to the strain relief and the catheter outer shaft had been separated.According to the complaint the hoop was flushed prior to removing the microcatheter and there was difficulty removing the microcatheter from the dispenser hoop, however there were no difficulties removing the microcatheter from the hoop in the lab.Per the dfu; ¿before removing the microcatheter from the dispenser coil, flush the dispenser coil with heparinized saline to wet the hydrophilic segment of the microcatheter.¿ from the damage to the microcatheter noted during analysis it appears there was inadequate flushing of the dispenser hoop which resulted in the microcatheter damage.Therefore; a probable cause of user error caused was assigned to the catheter shaft stretched and catheter shaft broken.
Event or Problem Description
During the analysis of the returned device, it was revealed that the catheter outer shaft had been separated.No clinical consequences reported to the patient.

• Brand Name: F/G RENEGADE 150/20/2TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 7107019
• Report Number: 3008853977-2017-00050
• Device Sequence Number: 19028264
• Product Code: KRA
• UDI-Device Identifier: 08714729301127
• UDI-Public: (01)08714729301127(17)190430(10)19314499
• Combination Product (Y/N): N
• PMA/510(K) Number: K973645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: 04/30/2019
• Device Catalogue Number: M001182590
• Device Lot Number: 19314499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR