MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR CATHETER/INTRODUCER COMBO SYSTEM

Model Number	C146F7
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, a latex free swan ganz model c146f7, lot 64582597 balloon developed a leak which was noted after the advanced providers were unable to deflate air from the balloon while advancing the swan through the right ventricle to the pulmonary artery.A stat x-ray was ordered, and a cardiology consultation was placed.Under surgeon advisement, the swan was withdrawn, where it was discovered that the balloon was actively leaking air.Patient demographics provided.There was no allegation of patient injury resulting from this event.
Additional Manufacturer Narrative
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.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.
Additional Manufacturer Narrative
Our product lab received one model c146f7 catheter.The balloon failed to stay inflated due to leakage from a pin hole near the central area of the balloon.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body.The customer report of a leak was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.

• Brand Name: CATHETER/INTRODUCER COMBO SYSTEM
• Common Device Name: CATHETER/INTRODUCER COMBO SYSTEM
• 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: 16335734
• Report Number: 2015691-2023-10697
• Device Sequence Number: 6221069
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)241002(11)221003(10)64582597
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K001063
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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: 10/02/2024
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 64582597
• Was Device Available for Evaluation?: No
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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