MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION PACEPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 931F75

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

We received one 931f75 paceport catheter for examination.The reported event of "tubing broke off from the orange hub" was confirmed.The catheter body was returned cut (clean sharp edges) 4cm distal of the backform and the distal section of the catheter was not returned.The rv pacing lumen hub appears to have broken off (rough edges) the extension tube and the rv hub was not returned.The extension tube appears to have been folded over and clamped.Due to the returned condition the balloon and thermistor could not be examined.As returned the through lumens are patent and do not leak.The returned injection site and needle catheter are not damaged.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.These catheters are typically inserted in patients who are either bradycardic or are undergoing a diagnostic procedure and need to be temporarily paced.They can also be placed emergently when a patient is experiencing hemodynamic instability.Therefore, problems with the catheter could lead to a delay in pacing, causing prolonged periods of bradycardia or hypotension, which has the potential to be associated with poor patient outcomes.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that during use the tubing broke off from the orange hub.The catheter was then capped off.The catheter was not need for pacing for this event.At this time no patient complications reported.Inquired of patient demographics, unable to be obtained.

Manufacturer Narrative

A definitive root cause was not able to be established.Documentation and the manufacturing process were verified and no deficiencies were found.No additional complaints were reported during the last 12 months related to ¿broken- extension tube¿.Therefore, a possible root cause for the broken hub could be related to the manipulation of the units during use at the hospital.The hub section was not returned to verify if the condition could be related to molding issue.Awareness training was conducted at the manufacturing site to prevent recurrence of this type of complaint.

• Brand Name: SWAN-GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 6186239
• MDR Text Key: 62797907
• Report Number: 2015691-2016-03801
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Model Number: 931F75
• Device Lot Number: 60452146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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