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

Model Number	782F75M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Ectopic Heartbeat (4443); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit 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.No corrective actions will be taken at this time.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.
Event or Problem Description
It was reported that the balloon of a swan ganz catheter came off during a procedure.No additional information available.
Additional Manufacturer Narrative
Per additional follow up with customer, the swan was floated in the usual manner prior to cabg.It took a couple of tries to achieve wedge.The balloon was able to deflate with passive return of air into syringe.About 15 min into procedure, ectopy was noted.The swan was suspected to have pulled back into the rv.Balloon was inflated to refloat to a wedge position.Syringe emptied without much resistance and failed to passively reinflate.Staff decided that the balloon was defective.Swan was removed and second swan was placed without difficulty.The first swan tip was examined and found that the ends of the balloon were present, but the center section of the balloon was possibly missing.There were no patient injuries reported.Device will be kept with hospital risk management.Corrections to the h6 codes clinical code 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: 17999630
• Report Number: 2015691-2023-17042
• Device Sequence Number: 6725324
• Product Code: KRA
• UDI-Device Identifier: 00690103197303
• UDI-Public: (01)00690103197303(17)250817(11)230818(10)65236657A
• 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): 07/18/2024
• 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: 65236657A
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 10/18/2023; 07/18/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/08/2023; 07/18/2024
• 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