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
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.Upon the device history record review results, a supplemental report will be sent.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.
Event or Problem Description
It was reported that a while prepping a latex-free swan-ganz, model c146f7, lot 64582597, the balloon did not completely deflate, and was therefore determined to be unsafe to float in the patient.
Additional Manufacturer Narrative
A device history record review was completed and documented that the device met all specifications upon distribution.
Additional Manufacturer Narrative
Our product evaluation lab received one model c146f7 catheter with monoject limited volume syringe.The balloon inflated clear and remained inflated for 5 timed minutes without leakage.The balloon was unable to be fully deflated.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or returned syringe.The balloon was found to have an eccentricity which was measured out of spec.The customer report of balloon did not completely deflate was confirmed on evaluation.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.As per the product evaluation, the balloon was unable to fully deflate.Additional information from the lab confirmed that the unit was able to pass the recommended introducer, per the ifu.This nonconformance is potentially related to human factors when performing the balloon bonding and balloon inspection.The balloon inspection was performed to all the units and correctly documented.This is an isolated case.A personnel acknowledgment was provided to the manufacturing personnel as part of the complaint investigation to inform the manufacturing personnel about this nonconformance.The catheter preparation section of the ifu indicates in step 2 to check balloon integrity by inflating it to the recommended volume.Check for major asymmetry and for leaks by submerging in sterile saline or water.Deflate balloon before insertion.

• 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: 16324128
• Report Number: 2015691-2023-10676
• Device Sequence Number: 12926264
• 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,Followup
• Report Date (Section B): 04/18/2023

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: 02/01/2023; 04/06/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 02/15/2023; 04/18/2023
• 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