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

Model Number PE074F5

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe was returned for evaluation.A 5f introducer was also attached to the catheter body between 76.5 cm and 89.7 cm proximal from the tip.Blood was visible on the balloon latex.Visual examination found that the catheter tip was completely broken off along the proximal electrode bonding site, and the proximal and distal lead wires were also completely broken off at the proximal electrode and the distal electrode, respectively.Residual adhesive was observed on the edge of the broken catheter tube.Cross surfaces of the broken lead wires were not insulated and appeared tapered, respectively.Cross surfaces of broken catheter tip appeared uneven and rough.Continuity testing confirmed the proximal circuit was continuous from the broken lead wire to the proximal electrode and broken lead wire to the proximal connector pin.The distal circuit was found to be continuous from the broken lead wire to the distal connector pin.No visible damage to the balloon, windings, or returned syringe was observed.Balloon inflation testing could not be performed due to the catheter tip breakage.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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, the catheter was pulled and torn by the patient.There were no patient complications noted for this 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.

Event Description

It was reported that the tip of the swan ganz catheter was ¿cut off¿ (pulled and torn) when the patient pulled the catheter.This occurred in the general ward on the third day of use.The catheter was removed from the patient.Although the insulation of the catheter was separated, the leadwire was still connected; therefore, the tip of the catheter was still connected.An x-ray was taken and it was confirmed that no missing catheter components remained in the patient¿s body.The patient had renal failure and had been receiving continuous hemodiafiltration (chdf).The catheter was inserted because bradycardia developed due to hyperkalemia.No further information could be obtained.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: PACING CATHETER
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7639877
• MDR Text Key: 112848833
• Report Number: 2015691-2018-02459
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

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: 01/08/2020
• Device Model Number: PE074F5
• Device Lot Number: 61209221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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
• Patient Age: 57 YR
• Patient Weight: 50