MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA); CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Manufacturer Narrative

One d97120f5 bipolar pacing catheter with an attached monoject volume limited 1.3 cc syringe at gate valve were returned for examination.The reported event of pacing issue was unable to be confirmed.No visible damage or abnormality was observed from the catheter body, balloon, windings and returned syringe.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 minutes without leakage.Visual examination was performed under microscope at 20x magnification and with unaided eye.A review of the manufacturing records indicated that the product met specifications upon release.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 it was unable to pace during use.The catheter was replaced and the problem was solved.Information such as the background of malfunction occurrence, what kind of surgery/examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information requested but unavailable.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)
• Type of Device: CATHETER, FLOW DIRECTED
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12562468
• MDR Text Key: 274716933
• Report Number: 2015691-2021-05460
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 63364493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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