MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

Hold for rw 2.8 it was reported that during use of this pacing catheter, the lead got cut during lead extraction with a laser sheath.The customer was uncertain whether it got cut by the laser or by some other cause.It was confirmed that catheter got cut off inside the patients body.There was no patient injury.No additional intervention was required in response to the event.Patient demographic information requested but unavailable.

Manufacturer Narrative

The device has been returned but the product evaluation has not been completed yet.A supplemental report will be forthcoming when the investigation is completed.A device history record review was unable to be completed as the lot number is unknown.

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc volume limited syringe at gate valve and a non-edwards contamination shield which was located on the catheter body between 40 cm and 53.3 cm proximal from catheter tip.The reported issue of catheter damage was confirmed.As received, the catheter tube was completely broken off at approximately 14.8 cm from catheter tip.The cross surfaces of the broken tube appeared blackened, and rough.The broken catheter body sections did not match up.Lead wires were also broken at the broken section.There was a puncture around half of the circumference near the broken section, and the puncture region was also blackened.A kink was found near the broken section also.It was able to open and lock the gate valve without any resistance.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.As part of the manufacturing process, 100 percent of the units go through an electrical continuity inspection and tip visual inspection.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.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.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18669506
• MDR Text Key: 334913039
• Report Number: 2015691-2024-00847
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2024
• 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