MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY BILIARY BALLOON PROBE; CATHETER, BILIARY, SURGICAL

Model Number 410235F

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

We received one 410235f catheter without the packaging for examination.The balloon and balloon windings were visually inspected for indication of damage or abnormality.The balloon was found to be ruptured in the central area between the windings and there is no indication of deterioration to the remaining latex.There appears to be a section of the latex missing.Both proximal and distal windings appear to be in good condition and the catheter body is also undamaged.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Per the product ifu the maximum inflation volume liquid for this catheter is 0.4ml.The customer indicated that more inflation volume was used than what is recommended.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that the balloon was inflated with 1.5 saline but once in the patient the balloon burst.No patient complications were reported.

• Brand Name: FOGARTY BILIARY BALLOON PROBE
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5496010
• MDR Text Key: 40646954
• Report Number: 2015691-2016-00763
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2017
• Device Model Number: 410235F
• Device Lot Number: 60039810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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