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

Model Number D97130F5

Device Problems Material Separation (1562); Component Missing (2306); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

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 to ensure that the device met all specifications upon distribution.(b)(4).

Event Description

It was reported that a swan-ganz bipolar pacing catheter had an issue upon removal from a 66 year-old female with aortic stenosis.The catheter had functioned appropriately during use, so there is no complaint regarding a failure to pace.Per the advanced practice nurse, she met resistance upon removal, so an empty syringe was attached to the sheath to cause negative pressure and she pulled harder.When the catheter came out, the balloon ("white coated") portion was missing and the wires were split into two.The physician advised her to aspirate from the sheath.They then removed the sheath to allow for some bleeding in anticipation of the balloon coming out, which it did.The blood loss was not specified.The patient did not incur any injury.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

Our product evaluation laboratory received one model d97130f5 catheter with a non-edwards contamination shield and monoject limited volume syringe.The body tube under the balloon latex was completely broken.The tube appeared to break at the proximal electrode lead wire port.There was a complete bond separation between the proximal electrode and the body tube.Adhesive was visible on the body tube at the bond location between the proximal electrode and catheter body.Both electrodes and balloon latex, along with the broken catheter body, were missing.One of the leadwires had a tapered end and appeared to be stretched.The customer report of "catheter was frayed" was confirmed on evaluation.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.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

Medwatch report # (b)(4) was received, which contained additional information.Additional patient information indicated a history of coronary artery disease and morbid obesity.The patient had undergone a transcatheter aortic valve replacement (tavr) procedure with insertion of a temporary transvenous pacer (ttvp) via left femoral approach.The ttvp was maintained post-operatively overnight secondary to heart block and bradycardia.The next day, the apn removed the ttvp.As previously reported, the balloon was deflated and resistance was met.The white luer cap was not loosened prior to removal.The report indicates that the balloon and a blood clot were recovered.It was also clarified that the originally reported lot number was taken from the lot number of other devices on the shelf and the actual lot number of the suspect catheter is unknown.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)
• 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: 8182146
• MDR Text Key: 131333096
• Report Number: 2015691-2018-05446
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Device Lot Number: 61524792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 143