MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that during use on a heart transplant patient, the physician assistant (pa) asked for assistance in advancing a swan catheter.The balloon was inflated when the pa asked the sales representative to pull the balloon back down, but the syringe would not passively deflate the balloon and it would not withdraw the air.The catheter was removed from the patient.Upon inspection, it was discovered that the balloon had a small air leak.There was no patient injury reported.The patient demographics were requested but were not released.The device is available for evaluation.

Manufacturer Narrative

The device is anticipated to be returned for evaluation, but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when the lot number is received.

Manufacturer Narrative

One 777f8 catheter with monoject limited volume syringe and non-edwards contamination shield was returned for examination.The reported issue air leak was confirmed.The balloon had leakage due to multiple tears and holes.The longest tear appeared to be about 0.05 on the balloon latex.The edges of the latex appeared to match at the damage locations.All through lumens were patent without any leakage or occlusion.There was no other visible damage or abnormality observed from catheter body or returned syringe.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 part of this monthly review.

• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13892754
• MDR Text Key: 296508416
• Report Number: 2015691-2022-04595
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)230907(11)210907(10)63950053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

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 Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63950053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1