MAUDE Adverse Event Report: VOLCANO CORPORATION REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 89000

Device Problems Break (1069); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2013

Event Type  malfunction  

Event Description

The revolution catheter was being used in a procedure to treat an lad with 90% occlusion.The user reported that while delivering the revolution catheter for the second ivus recording inside the body, the image disappeared.The user did not notice any damage to the device upon removal from the patient.The procedure was successful completed with another volcano product.No additional intervention ws required due to the device malfunction.There was no patient injury or adverse event reported.The patient was released from the hospital according to the original treatment plan and the patient is reported to be in good condition.The revolution catheter was received by the manufacturer and during evaluation of the device on (b)(6) 2014, it was observed that the proximal shaft of the catheter was broken.

Manufacturer Narrative

(b)(4).The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints have been reported for this failure mode within this lot.The device was returned and investigated in accordance with volcano policy.During visual inspection of the device, a shaft separation was observed in the proximal shaft at approximately 47.4cm from the distal tip of the catheter.The shaft was discolored at the site of the separation, indicating it has been kinked prior to the separation.The drive cable was also kinked at the separation, indicating it had been kinked prior to the separation.The drive cable was also kinked at the separation location.All portions of the catheter were accounted for.When functionally tested, the device was recognized but failed to produce an image.The most likely cause of the reported image failure was the damaged drive cable, which resulted in an electrical failure within the imaging core.The observed damage to the device was likely due to user handling post-procedure, however we were unable to conclusively determine when or how the damage occurred.The user did not report damage to the device, only the image failure.After the catheter experienced the image failure, the user stopped use of the device and completed the procedure with another volcano product.No patient injury was reported due to the device malfunction.

• Brand Name: REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• Manufacturer Contact: denise sterns ; 3721 valley centre dr.; ste 500; san diego, CA 92130 ; 8587204178
• MDR Report Key: 3847653
• MDR Text Key: 4684517
• Report Number: 2939520-2014-00016
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2013

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: 10/31/2014
• Device Model Number: 89000
• Device Catalogue Number: 89000
• Device Lot Number: 035 20000859
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1