MAUDE Adverse Event Report: VOLCANO CORPORATION PIONEER PLUS CATHETER; IVUS RE-ENTRY CATHETER

Model Number PPLUS 120

Device Problems Device Sensing Problem (2917); Material Protrusion/Extrusion (2979)

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

Event Date 02/28/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device history record review: a review of the device batch records was performed including raw materials, in-process, finished goods and sterilization and there were no non-conformances or capa's opened in relation to the nature of the complaint.The devices met all raw materials, in-process, finished goods and sterilization specifications upon release of the product.All dimensional verification, packaging and delivery system inspections were acceptable.The device evaluation: the lost image failure was confirmed by the investigation.The evaluation determined that a weld leg was fractured and the device failed the channel match test, and no image appeared.During the evaluation of the device, it was noted that the blue vestamid tubing had a tear/cut in it and that a portion of the rx lumen, which is embedded in the vestamid tubing, was protruding.Although the root cause of this failure cannot be definitively determined, this defect typically occurs when the proximal end of the guide wire is inadvertently pulled toward the distal tip of the device.The guide wire in turn may tear/cut the vestamid tubing resulting in a portion of the rx lumen being pulled away from the vestamid tubing.A clinical assessment of this failure is being conducted and the results of the assessment will be included in a supplemental report.

Event Description

The user reported a partial loss of image while using a pioneer plus catheter.Upon initial device evaluation, it was noted that the rx (rapid exchange) lumen was partially protruding from the device.

• Brand Name: PIONEER PLUS CATHETER
• Type of Device: IVUS RE-ENTRY CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer Contact: denise stearns, assoc. vp ; 3721 valley centre dr., ste. 500; san diego, CA 92130 ; 8587204170
• MDR Report Key: 5754962
• MDR Text Key: 48627962
• Report Number: 2939520-2014-00037
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: PPLUS 120
• Device Catalogue Number: PPLUS 120
• Device Lot Number: 06101447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1