MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310030

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

Same case as mfr id # 2134265-2014-06178.Reportable based on analysis completed (b)(6) 2014.It was reported that during preparation of the device it was noted that the rotalink burr was unable to load onto the rotalink wire.The procedure was completed with another rotalink device.No patient complications were reported.Examination of the returned device revealed a wire fragment was found in the annulus of the burr.

Manufacturer Narrative

The catheter and the advancer were connected upon return.A test guidewire was attempted to be inserted through the device however a resistance was encountered and the wire would not advance through the annulus.Upon inspection of the device it was found the burr annulus was blocked with dried saline.The burr was soaked in warm water and the dried saline dissolved.The burr annulus was again inspected and there was evidence of a wire present in the annulus of the burr.The advancer and the catheter were disconnected to investigate if the wire was running through the entire length of the device.There was no evidence of the wire during the disconnection.The test guide wire was loaded through the disconnected handshake connector of the catheter and advanced towards the burr in an attempt to push the wire fragment through.The wire advanced to the end of the coil however a resistance was encountered and the wire did not advance through the burr.The wire was removed from the catheter and an attempt was made to load the wire through the burr.This was successful and it is possible the wire was successfully loaded due to the dislodgement of the wire that was present in the annulus.The advancer and the catheter were reconnected and the test guide wire was loaded through the entire device with no resistance encountered.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 prior to patient contact.(b)(4).

• Brand Name: ROTALINK? PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• 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: 4167022
• MDR Text Key: 21523587
• Report Number: 2134265-2014-06380
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• 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: 09/17/2014

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: 03/31/2016
• Device Model Number: H749236310030
• Device Catalogue Number: 23631-003
• Device Lot Number: 0016874992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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