MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

Model Number PE074F5

Device Problems Break (1069); Inflation Problem (1310)

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

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.Blood was observed from catheter tip.Visual examination found that the catheter tip and the distal lead wire were completely broken off near the inflation port.The balloon was found to be ruptured around the circumference at the position near the catheter tip breakage.The broken section was not returned.Cross surface of the broken lead wire appeared to be tapered.Cross surface of the broken catheter tip appeared uneven and rough.Continuity testing was performed on the proximal circuit and there were no open, intermittent, or short conditions observed.Continuity testing from the distal circuit between the broken section and the distal electrode connector pin also confirmed no open, intermittent, or short condition.No visible damage to the proximal windings or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon inflation issue could not be confirmed; however, the catheter tip and the distal lead wire were found to be completely broken off during the evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.This complaint involves swan ganz pacing catheters where the catheter tip and distal lead wire were completely broken off near the inflation port.Detached tips have the potential to cause peripheral or pulmonary embolization.A detachment of the tip of the catheter will usually require some type of intervention to retrieve the detached fragment in order to prevent long-term complications.In this case the broken tip was not returned so a complete analysis of the catheter and potential case of the catheter tip separation is unable to be established.There was no report of a required intervention or patient complications.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.

Event Description

It was reported that the balloon of the swan ganz catheter did not inflate during use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7957248
• MDR Text Key: 123678783
• Report Number: 2015691-2018-04163
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2020
• Device Model Number: PE074F5
• Device Lot Number: 61209876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1