MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACEPORT OXIMETRY; CATHETER, OXIMETER, FIBER-OPTIC

Model Number	780F75M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 780f75m catheter with monoject limited volume syringe was returned for evaluation.The customers report of balloon rupture was confirmed.The catheter balloon was found to be torn from proximal and distal bonding sites.The central area of balloon latex was missing.Residual latexes were observed from the distal and proximal bonding sites.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body or syringe.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was completed 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 monthly, 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, before use, the balloon on the swan-ganz catheter was ruptured.The device was being used with a hemosphere monitor.There was no patient injury.The product was returned for evaluation and the central area of the balloon latex was missing.

• Brand Name: SWAN-GANZ PACEPORT OXIMETRY
• Common Device Name: 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 Key: 15577660
• Report Number: 2015691-2022-08478
• Device Sequence Number: 17847901
• Product Code: DQE
• UDI-Device Identifier: 00690103197341
• UDI-Public: (01)00690103197341(17)231026(11)211026(10)64014088
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K905458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: 780F75M
• Device Catalogue Number: 780F75M
• Device Lot Number: 64014088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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