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 Failure to Capture (1081)

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

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review has been initiated and a supplemental report with the findings will be sent with the results.Udi: (b)(4).

Event Description

It was reported that a swan-ganz pacing catheter failed to capture during use.The bipolar pacing catheter was placed in preop and when under fluro in the or suite, the anesthesiologist was not able to achieve capture of the pacing wire.They changed pacing cables, pacing red pins, pacer box and finally the pacing wire.The new wire was able to capture and pace.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Per follow-up for product return, the customer reported that the device was discarded during the procedure.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported 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.

Manufacturer Narrative

The customer returned the suspect device for evaluation, despite originally reporting it had been discarded.Our product evaluation laboratory received one pacing catheter with an attached monoject limited volume syringe.Continuity testing confirmed a full open condition of the distal circuit at the tip of the catheter.The proximal circuit was found to be continuous.The distal lead wire was found to be broken near the distal electrode.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.No visible damage or inconsistency was observed from the catheter body, balloon, windings, and the returned syringe.The customer report of a pacing failure was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 9307727
• MDR Text Key: 194596899
• Report Number: 2015691-2019-04180
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/24/2019

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: 07/23/2021
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 62431362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 12/20/2019; 07/23/2020
• Supplement Dates FDA Received: 11/18/2019; 12/20/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1