MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that the catheter was found broken and separated during use.The catheter was inserted into the patient in catheter room and then the patient was managed in the intensive care unit (icu).The catheter was functioning without any problem in the catheter room and icu.When the patient was transferred to general ward from the icu, electrocardiogram disappeared and breakage in the middle of the catheter was discovered.Breakage was unlikely caused by the patient because the patient was with low level of consciousness to begin with, and could not move.According to the customer, the catheter had been placed for about one month.The catheter was replaced with a new pacing catheter.There was no remain of broken catheter inside the patient's body and no additional treatment or procedure was required.Information including the kind of surgery/examination the catheter was used for and if the patient had cardiac conduction defect was unknown.There was no patient injury.Patient demographic information requested but unavailable.

Manufacturer Narrative

Our product evaluation lab received one model d97120f5 embolectomy catheter.The customer report of the catheter was found broken and separated was confirmed.As received, the catheter tube was completely broken off at approximately 83.3 cm from catheter tip and the catheter tube was wavy between 30 cm and the broken location.The cross surfaces of the broken tube appeared uneven and rough, and the broken tube appeared stretched around 80 cm marker.The broken catheter body sections did not match up.It was also observed that the catheter tube was collapsed at approximately 83.3 cm from catheter tip.The lead wires were found to be broken off near the tube broken location.Continuity testing confirmed no open, intermittent, or short condition from the distal and proximal circuits between the broken section and the electrode connector pins and between the broken section and the electrodes.No visible damage was observed from balloon, windings and returned syringe.The engineering evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Manufacturer Narrative

Our product evaluation lab received one model d97120f5 pacing catheter.The customer report of the catheter was found broken and separated was confirmed.As received, the catheter tube was completely broken off at approximately 83.3 cm from catheter tip and the catheter tube was wavy between 30 cm and the broken location.The cross surfaces of the broken tube appeared uneven and rough, and the broken tube appeared stretched around 80 cm marker.The broken catheter body sections did not match up.It was also observed that the catheter tube was collapsed at approximately 83.3 cm from catheter tip.The lead wires were found to be broken off near the tube broken location.Continuity testing confirmed no open, intermittent, or short condition from the distal and proximal circuits between the broken section and the electrode connector pins and between the broken section and the electrodes.No visible damage was observed from balloon, windings and returned syringe.An engineering evaluation was preformed to assess for any manufacturing related processes which could be correlated to the complaint, a manufacturing root cause could not be confirmed.The ifu indicates that: the incidence of complications increases significantly with indwelling periods longer than 72 hours.The lot number was not provided thus a device history record was not reviewed.Corrections to the h6 codes investigation findings and investigation conclusions were made.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 a part of the monthly review.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18606762
• MDR Text Key: 334100485
• Report Number: 2015691-2024-00656
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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