MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	123F6P
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 123f6 with 1ml syringe barrel was returned for evaluation.The reported issue of deflation difficulty was unable to be confirmed.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 2 seconds without a syringe attached.Per ifu, passively deflate the balloon by removing the syringe from the gate valve.Balloon deflation time was within specification.Max.Deflation time from full capacity is 4 seconds per eas556 rev bp without a syringe attached.Distal lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.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.
Event or Problem Description
It was reported that the balloon did not deflate.This was before use in a patient, during device prep.The nurse tried to deflate the balloon after detaching the syringe, but it would not deflate completely.She inflated it again and removed the syringe, but it would still not deflate.There is no patient involvement.
Additional Manufacturer Narrative
The issue of balloon deflation difficulty was not confirmed.The failure mode could not be confirmed to be associated with a manufacturing/design defect.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 TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 12685865
• Report Number: 2015691-2021-05894
• Device Sequence Number: 4099985
• Product Code: DQO
• UDI-Device Identifier: 00690103000375
• UDI-Public: (01)00690103000375(17)230226(11)210226(10)63643181;(01)50690103000370(17)230226(11)210226(10)63643181
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMEN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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 Expiration Date: 02/26/2023
• Device Model Number: 123F6P
• Device Catalogue Number: 123F6P
• Device Lot Number: 63643181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2021
• 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