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

Model Number 89000

Device Problems Material Separation (1562); Physical Resistance (2578)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

During insertion of the catheter inside the body, the physician reported that some resistance was met.During pullback as the catheter was being removed from the co-pilot device, the sheath that protects the distal end of the catheter was ripped off.They were however able to remove the outer sheath successfully without any issue.No pt injury or adverse events were reported.Another same product was used to successfully complete the procedure.

Manufacturer Narrative

(b)(4).The mfg documentation for this device was reviewed and the device met all quality and mfg release criteria.To date, no other complaints were reported for this same failure mode within this lot.The device has been rec'd by the mfr and is currently being investigated.A supplemental report will be submitted as soon as the investigation is completed.We will continue to monitor complaints for this failure mode via our standard complaint review process and data trending activities.

• Brand Name: REVOLUTION 45MHZ RATIONAL 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: kathy turner ; 3721 valley centre dr; ste 500; san diego, CA 92670 ; 8587641240
• MDR Report Key: 4460486
• MDR Text Key: 20788278
• Report Number: 2939520-2015-00003
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K080891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: 89000
• Device Catalogue Number: 89000
• Device Lot Number: 0035 20033156
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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