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

Model Number 774F75

Device Problem Leak/Splash (1354)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that during an acute aortic dissection, the catheter was unable to measure svo2 and medication leakage was observed from the optical module connector when the customer injected medication from the proximal injectate lumen on the first day of use.The detail of the medication is unknown.There were no impacts such as extension of the operation time or additional treatment due to the medication leakage.The catheter could not be replaced since it was placed in the patient body.There were no error messages observed on the hemosphere monitor.The patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One 774f75 catheter was returned with attached monoject 1.5 cc limited volume syringe, 2 three way stopcocks, and non edwards introducer with contamination shield, which is located on the catheter body from 16.5 cm to distal end of backform.The reported issues of svo2 measurement and leakage was confirmed.As received, blood residue was visible at the tip of the optical module connector and around the adhesive.The catheter failed in-vitro calibration.There was no damage observed from the catheter body.The optical module connector was opened.Although blood was observed inside the connector, no light leakage was observed from the optical fibers in the optical module connector.The fiber extension tube was cut in half just distal of the optical module connector for leak testing.Leakage was observed from proximal lumen hub when air was injected into fiber lumen.Leak test found interlumen leakage in the backform between proximal injectate lumen and optical fiber lumen.The distal lumen was patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.Both distal and proximal heater bonding were torn and blood was observed inside the heater shrink wrapping.Both torn edges appeared to match up.There was no other visible damage observed on catheter body, balloon, and returned syringe.The product was sent to irvine for further evaluation.From the visual examination indentations were found around the circumference of the optical extension tube at 1.5, 2, 2.2 and 2.6 distal from the optic connector.The optic fibers in the extension tube were damaged.The locations of the damages on the fibers were aligned to the locations of the indentations on the extension tube.A review of the manufacturing records indicated that the product met specifications upon release.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 THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• MDR Report Key: 12362484
• MDR Text Key: 267966062
• Report Number: 2015691-2021-04839
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63426157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2020
• 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
• Treatment: HEMOSPHERE MONITOR; HEMOSPHERE MONITOR