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

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that on a (b)(6) female patient the catheter was unable to sense or pace during a pacemaker replacement.When the customer checked the spontaneous rate with the programmer, the rate was 30 bpm and there was no spontaneous rate observed.The customer decided to use the pacing catheter since the patient would have had no heart rate during the pacemaker replacement however, it was unable to sense or pace.The catheter was replaced, and it was able to sense and pace so the pacemaker replacement was performed successfully.There were no patient complications.

Manufacturer Narrative

One bipolar pacing catheter with an attached monoject volume limited 1.3 cc syringe at gate valve was returned for examination.The reported event of sensing and 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.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.As part of the catheter manufacturing process a 100% of the units go through an electrode and tip inspection, and continuity test.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.Correction- in the initial submission b5 section the patient was listed as 94 years old.However, the correct age at the date of the procedure should have reflected 95 years of age.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• 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: 12362403
• MDR Text Key: 267964996
• Report Number: 2015691-2021-04838
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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: 02/10/2022
• Device Model Number: PE074F5
• Device Lot Number: 62934851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 95 YR
• Patient Weight: 45