MAUDE Adverse Event Report: VOLCANO CORPORATION TRAK BACK II DISPOSABLE PULLBACK DEVICE; PULL BACK DEVICE

Model Number 91003

Device Problems Nonstandard Device (1420); Delivered as Unsterile Product (1421); Failure of Device to Self-Test (2937)

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

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Transportation testing performed for the trak back ii device resulted in an 11% failure rate for bubble emission.Upon review, the determination was made that the sterility of the product following the shipment process might be compromised.To date, volcano corporation has not received any reports from customers/users regarding this issue.Additionally, there are no reported cases of patient injury or adverse events that could be potentially related to this failure mode.

Manufacturer Narrative

Reference #2939520-8/14/14-001r.During planned manufacturing transfer activities, a routine review of the design history record was conducted.During this review, it was discovered that the transportation validation documentation could not be located.A transportation validation was conducted.During the bubble emission portion of the test, (b)(4) packages tested failed the bubble emission test.Volcano initiated a voluntary recall of all lots of trak back ii distributed within the previous 25 months.Further information regarding this activity will be communicated to fda via routine communications relative to the above referenced recall notification number.

• Brand Name: TRAK BACK II DISPOSABLE PULLBACK DEVICE
• Type of Device: PULL BACK DEVICE
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA 95670
• Manufacturer Contact: kathy turner ; 3721 valley centre drive; suite 500; san diego, CA 92130 ; 8587641240
• MDR Report Key: 4081141
• MDR Text Key: 4893506
• Report Number: 2939520-2014-00073
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/30/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 91003
• Device Lot Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2939520-8/14/14-001R
• Patient Sequence Number: 1