MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION PACEPORT CATHETER

Model Number 931F75

Device Problem Break (1069)

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

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.No actions will be taken at this time.A device history record review has been initiated to document if the device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that a during a cabg procedure, 5 centimeters of the 931f75 swan-ganz catheter was missing from the end.Prior to insertion, the anesthesiologist, dr.Christian stated he flushed all the ports, tested the balloon, which inflated normally and was unremarkable.The balloon did inflate appropriately and had no leaks.The balloon was then deflated prior to insertion.There were 2 anesthesiologists managing this catheter, dr.Christian did the necessary pre-testing of the catheter, flushing it, testing the balloon, inserting the catheter, and then he handed the patent off to dr.Herren who was monitoring the catheter while it was in place and identified the spike in the pressure.The anesthesiologist identified that the transducer was leaking and began attempts to aspirate or flush the catheter thinking it was possibly a blood clot, both of which were unsuccessful.When readings could not be corrected, attempts to deflate the balloon were unsuccessfully, however catheter was very easily backed up.The catheter was exchanged for a different catheter.The used catheter was easily pulled and placed on a side table and a new swan ganz catheter was flushed, checked, inserted, and the balloon inflated.They proceeded to work normally throughout the remainder of the case.It was at this point that dr.Herren inspected the used catheter that had been placed on the side table and identified that the end appeared to have been singed or pinched off and approximately 5 centimeters was missing from the end.The care team to decided to intentionally leave the piece retained overnight and retrieve the swan ganz piece via ir procedure the next morning, which was found in the pulmonary artery.The procedure was done successfully.Approximately 6 days later, the patient was discharged home at his baseline.

Manufacturer Narrative

Our product evaluation lab received one swan-ganz catheter model 931f75 with attached volume limited monoject syringe and non-edwards contamination shield.Dry blood was visible at the site of damage on catheter body.As received catheter body was found completely broken at approximately 6cm proximal from the tip and returned in two sections.Catheter body appeared pinched at the site of damage for both sections.Thermistor bead and wires were exposed from proximal section but appeared intact.The thermistor was found to read 37 degrees celsius when submerged into a 37-degree celsius water bath.Thermistor temperature reading is accurate per hemosphere manual.The customer photos appeared consistent with lab findings.No other visible damage was observed from returned catheter.A device history record review has been completed and documented that the device met all specifications upon distribution.The customer report of damage to catheter body was confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A supplemental report will be submitted if there are any findings.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: SWAN-GANZ THERMODILUTION
• 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: 16998279
• MDR Text Key: 315911797
• Report Number: 2015691-2023-13217
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00690103003925
• UDI-Public: (01)00690103003925(17)250206(11)230207(10)64848610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 931F75
• Device Catalogue Number: 931F75
• Device Lot Number: 64848610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male