MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN F/G RENEGADE 150/10/2TIP; CATHETER, CONTINUOUS FLUSH

Catalog Number	M001182570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device can't be removed from the hoop despite flushing several times, finally the device was stretched and broken.There was no patient involvement.
Additional Manufacturer Narrative
The dhr (device history record) review confirmed that there is no indication that the device, labeling or packaging failed to meet its specifications when released.The renegade catheter was examined after decontamination and it was observed that the catheter was severely stretched on its proximal shaft at 2.6cm distal to the strain relief.The catheter outer shaft had been separated and inner braided shaft was severely stretched and also separated.Additional information provided by the customer indicated that the device could not be removed from the dispenser hoop despite flushing several times and the catheter was stretched and broken during attempted removal.The anomalies found on the product appeared to be due to excessive pulling of the device during removal.Although it was reported that the hoop was flushed several times, it is possible that the flush setup was incorrect/inadequate.During analysis, the catheter was able to be pulled out of the dispenser coil without any difficulties.Based on the investigation, a probable cause of handling damage has been assigned to the reported event and analyzed anomalies, as it is believed the issue is due to handling of the product upon removal from its packaging.
Event or Problem Description
It was reported that the device can't be removed from the hoop despite flushing several times, finally the device was stretched and broken.There was no patient involvement.

• Brand Name: F/G RENEGADE 150/10/2TIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 8075987
• Report Number: 3008853977-2018-00061
• Device Sequence Number: 1733070
• Product Code: KRA
• UDI-Device Identifier: 08714729301110
• UDI-Public: 08714729301110
• 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,Followup
• Report Date (Section B): 12/31/2018

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: 08/20/2020
• Device Catalogue Number: M001182570
• Device Lot Number: 21156625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Received by Manufacturer: 10/21/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1