MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK RENEGADE STC 18 MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK680

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-01381.It was reported that the coil was broken.The patient was undergoing an embolization procedure.Triaxial access to the right colic artery was obtained with a two non bsc catheters and a 130cm renegade stc microcatheter.Two interlock coils, 4mm x15cm and 4mm x 8cm, were implanted in the lesion.The third coil, a 4mm x 15cm interlock, was then advanced in the renegade.When more than half of the coil was deployed, the physician noted that the renegade was raising itself up due to strain from the interlock inside; possibly due to the length of the coil and inadequate space to implant it.The physician attempted to withdraw the coil back into the microcatheter, but resistance was noted.A small piece of the interlock broke off and released into the superficial mesenteric artery (sma).While attempting to withdraw the coil, the coil was stretched.The coil was pushed out of the renegade with a coil pusher, with no issues noted.The bleeding at the target lesion was stopped, therefore the procedure was completed.An imaging scan confirmed the location of the coil fragment in the sma was stable.No further patient complications were reported and the patient's condition is stable.

Manufacturer Narrative

Age at time of event: "1940." device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: RENEGADE STC 18 MICROCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3699109
• MDR Text Key: 4334108
• Report Number: 2134265-2014-01876
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K023681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2014

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
• Device Operator: Health Professional
• Device Model Number: UNK680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: COIL: 4MM X 15CM INTERLOCK