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

Model Number M001182850

Device Problems Device Damaged Prior to Use (2284); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter shaft peeled off.A 105/20 renegade hi-flo was selected to treat the target lesion located in the liver artery.During the procedure, outside the patient, the renegade was stuck in the dispenser hoop.The device was retracted forcibly and it was noted that the outer material of the shaft peeled off.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device lot number ¿ corrected from 17492444 to 17492442.Device manufactured date - corrected from 12/02/2014 to 12/01/2014.Device evaluated by mfr.: device was returned for analysis.A visual inspection revealed that the shaft was broken and stretched 9.6cm from the hub of the microcatheter and the inner liner was exposed 18.2cm in length.A coating confirmation test was carried out to check the presence and integrity of the coating.The test revealed the presence of coating damage.Most likely excessive force used in attempting to remove the microcatheter from the hoop caused the damage to the coating.There was no peeling or missing coating.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the catheter shaft peeled off.A 105/20 renegade hi-flo was selected to treat the target lesion located in the liver artery.During the procedure, outside the patient, the renegade was stuck in the dispenser hoop.The device was retracted forcibly and it was noted that the outer material of the shaft peeled off.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.

• Brand Name: RENEGADE¿ HI-FLO¿
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5035670
• MDR Text Key: 24416062
• Report Number: 2134265-2015-05649
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: M001182850
• Device Catalogue Number: 18-285
• Device Lot Number: 17492442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1