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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC
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EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC Back to Search Results
Model Number 777F8
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Manufacturer Narrative
One 777f8 catheter with attached monoject 1.5 cc limited volume syringe was returned for examination.The customer's report of the the balloon not inflating was confirmed during evaluation.The balloon was found to be ruptured at central area of balloon latex and the ruptured edges were not able to match up.As received, blood was observed inside the balloon, gate valve, and returned syringe.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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 part of this monthly review.
 
Event Description
It was reported that the balloon of the swan-ganz cco catheter did not inflate in the body during use.There was no patient injury or complications.During the product evaluation, the balloon was found to be ruptured at central area of balloon latex and the rupture edges were not able to match up.
 
Manufacturer Narrative
One 777f8 catheter with attached monoject 1.5 cc limited volume syringe was returned for examination.The customer's report of the the balloon not inflating was confirmed during evaluation.The balloon was found to be ruptured at central area of balloon latex and the ruptured edges were not able to match up.As received, blood was observed inside the balloon, gate valve, and returned syringe.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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 part of this monthly review.
 
Event Description
It was reported that the balloon of the swan-ganz cco catheter did not inflate in the body during use.There was no patient injury or complications.During the product evaluation, the balloon was found to be ruptured at central area of balloon latex and the rupture edges were not able to match up.
 
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Brand Name
SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
Type of Device
CATHETER, OXIMETER, FIBER-OPTIC
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 Key12992370
MDR Text Key285188363
Report Number2015691-2021-06813
Device Sequence Number1
Product Code DQE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040287
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2021
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 Date03/04/2023
Device Model Number777F8
Device Catalogue Number777F8
Device Lot Number63661460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/02/2021
Initial Date FDA Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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