MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP; CATHETER, CONTINUOUS FLUSH

Model Number	782F75M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon of a swan ganz catheter was missing during a pre op open heart surgery.After catheter was floated and placed into the pa, ventricular ectopy was noticed.It was suspected that the catheter flipped back into the right ventricle.Physician pulled back into the svc, ra to refloat the catheter, but balloon did not inflate.Physician removed the catheter from the sheath to examine and noticed a small donut shaped rubberized material at the proximal and distal area of the balloon and that the middle section of the balloon was missing.A new swan ganz was exchanged and used without issues.The surgery went without complications.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product investigation.A supplemental report will be forthcoming with the evaluation when completed.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 a part of the monthly review.
Additional Manufacturer Narrative
An imaging evaluation was completed with photos provided by customer.Per the evaluation, the reported event of middle section of the balloon was missing was confirmed.1 image was reviewed.Catheter balloon was found to be torn from proximal and distal bonding sites.The central area of balloon latex was missing.Residual latex were observed from the distal and proximal bonding sites.Due to the hospital risk management retaining the device, no product will be returned.It is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Corrections to the h6 codes type of investigation and investigation conclusions were made.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 a part of the monthly review.
Additional Manufacturer Narrative
Udi related data quality updates only the following are additional product codes for this device: dqo, catheter, intravascular, diagnostic.Dyg, catheter, flow directed.Dqe, catheter, oximeter, fiberoptic.The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid): d1 brand name: swan-ganz vip; d2a common device name: catheter, continuous flush; d2b device product code: kra.

• Brand Name: SWAN-GANZ VIP
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17999616
• Report Number: 2015691-2023-17040
• Device Sequence Number: 14489380
• Product Code: KRA
• UDI-Device Identifier: 00690103197303
• UDI-Public: (01)00690103197303(17)250818(11)230819(10)65236657
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K926450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/18/2025
• Device Model Number: 782F75M
• Device Lot Number: 65236657
• Was Device Available for Evaluation?: Yes
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 07/18/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/08/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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