MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; SWAN GANZ VIP TD CATHETER110CM

Model Number	831F75
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one 831f75 with monoject limited volume syringe.The catheter body was deformed between 61cm to 72cm from the tip.The catheter appeared flattened and torn at the deformed location.The thermistor lead wires were exposed at parts of the deformed body.The balloon latex appeared deteriorated.Multiple cracks were evident on balloon latex.Leakage was observed through cracks on the deteriorated balloon.The balloon edges did not appear to match up at the cracks.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.It appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.All thru lumens were patent without any leakage or occlusion.A device history record review was completed and documented that the device met all specifications upon distribution.The report of the tubing appeared flat, and the wire exposed was confirmed.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 an 831f75 swan-ganz catheter was compromised.Between the 60-80cm mark, the tubing appeared flat, and the wire was exposed.There was no allegation of patient injury.
Additional Manufacturer Narrative
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 or design defect.A previous product risk assessment addresses the failure of balloons with fragmentations for swan ganz models.The ifu contains instructions on the handling of the unit, as well as the proper storage instructions and shelf life of the product.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 VENOUS INFUSION PORT (VIP) CATHETER
• Common Device Name: SWAN GANZ VIP TD CATHETER110CM
• 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: 16492230
• Report Number: 2015691-2023-11295
• Device Sequence Number: 20393215
• Product Code: DYG
• UDI-Device Identifier: 00690103003031
• UDI-Public: (01)00690103003031(17)240920(11)220921(10)64577505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 09/20/2024
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Device Lot Number: 64577505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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