MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS; CATHETER, FLOW DIRECTED

Model Number	141F7
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of a 141f7 swan ganz catheter was not able to deflate.Event occurred during device prep.There was no patient injury.Product is available for return.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the investigation is completed.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 a part of the monthly review.
Additional Manufacturer Narrative
Our product evaluation lab received one model 141f7 swan-ganz catheter.The customer report of air would not release from the balloon was unable to be confirmed.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 1 second without the syringe attached.Maximum deflation time from full capacity without a syringe attached is 4 seconds.Per the ifu instructions, passively deflate the balloon by removing the syringe and opening the gate valve.All through lumens were patent without any leakage or occlusion.No visible damage was observed on catheter.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect and no corrective actions will be taken at this time.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• Brand Name: SWAN-GANZ & EDSLAB HEPARIN COATED CATHETERS
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: katheryn richards ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18611090
• Report Number: 2015691-2024-00671
• Device Sequence Number: 7416822
• Product Code: DYG
• UDI-Device Identifier: 00690103000504
• UDI-Public: (01)00690103000504(17)250430(11)230501(10)65059499
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K812563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 141F7
• Device Lot Number: 65059499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown