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

Model Number 931F75

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.

Event Description

It was reported that during use of a swan-ganz catheter, the balloon was unable to be passively deflated after 1.5 ml of air was injected.The balloon had successfully been inflated/deflated prior insertion.Upon removal, the balloon appeared intact and could be inflated and deflated ¿without concerns.¿ there was no patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Per follow-up with the customer, the date of occurrence was clarified as (b)(6) 2019 and patient demographics cannot be provided due to the customer¿s confidentiality policy.

Manufacturer Narrative

Our product evaluation laboratory received one model 931f75 with a monoject limited volume syringe and non-edwards contamination shield.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.The balloon deflated within 2 seconds without a syringe attached, which was within specification of 4 seconds for balloon deflation (without a syringe attached).All through lumens were patent without any leakage or occlusion.No visible damage was observed on the catheter or the returned syringe.The customer report of "unable to passively deflate" was not confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.Balloon deflation difficulty can result in an occlusion of blood flow and possible distal ischemia.In this case no patient injury was noted.It is unknown if user or procedural factors contributed to this event.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.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 9555907
• MDR Text Key: 188675189
• Report Number: 2015691-2020-10055
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 931F75
• Device Lot Number: 62065217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1