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

Model Number M001181330

Device Problems Material Perforation (2205); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-05201.It was reported that a microcatheter perforation occurred.A 130/20 renegade¿ stc 18 and a 3mm/3.3 mm vortx¿ diamond - 18 were used for embolization of the gastroduodenal artery.During procedure, the coil was inserted and resistance was noted in the catheter just distal to the hub.The physician put the stiff end of the coil pusher in and attempted to advance the coil.The physician exerted a lot of force with the stiff end of the coil pusher and perforated the lumen of the microcatheter.The coil was removed together with the microcatheter as a unit.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: investigation completed.The device was returned for evaluation.Device analysis noted that the secondary strain relief (ssr) is perforated 8.7cm from the proximal end of the catheter.The catheter was inspected by rotating the shaft 360° to inspect for any bumps or kinks.Two kinks were present on the catheter; 107.3cm from the proximal end and 31.8cm from the proximal end.A 0.018" guidewire ) was advanced through catheter to inspect for blockage/coil present.Resistance noted ~18cm from the proximal end.Guidewire was inserted through the distal end of the catheter and resistance was met ~16cm from the distal end of the catheter.Water was flushed through the device using a syringe to inspect for any blockages/leaks.A leak was noted where the shaft is perforated on the ssr.The catheter itself was left to soak in warm water for an hour to assist in removing blockage/coil from inside catheter.After the unit was soaked in warm water, an attempt was made to flush the coil out of the catheter and using a mandrel to push coil out.These attempts were unsuccessful.Coating confirmation test was performed using crystal violet.Black shiny marks were present on the shaft which is a sign of coating damage.No pealing or flaking coating was present during this test.The coil had to be cut out of the catheter.The coil was removed successfully from the catheter.As the coil was pushed out of the catheter, a plastic material exited with the coil.A significant amount of blood was blocked inside the catheter along with blood clots.This may have contributed to resistance inside the catheter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu instructs the user to use a continuous flush throughout the procedure.(b)(4).

Event Description

It was further reported that intermittent flushing was performed.

• Brand Name: RENEGADE? STC 18
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4055446
• MDR Text Key: 4901912
• Report Number: 2134265-2014-05200
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup
• Report Date: 08/05/2014

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 Expiration Date: 02/29/2016
• Device Model Number: M001181330
• Device Catalogue Number: 18-133
• Device Lot Number: 15983312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2013
• 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: VORTX-18 DIAMOND 3MM/3.3 MM
• Patient Age: 30 YR