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

Model Number 782F75M

Device Problem Material Separation (1562)

Patient Problems Ectopic Heartbeat (4443); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

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 Description

It was reported that the balloon of a swan ganz catheter came off during a procedure.No additional information available.

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.

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 OXIMETRY THERMOD
• Type of Device: CATHETER, OXIMETER, FIBER OPTIC
• 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
• MDR Text Key: 326473859
• Report Number: 2015691-2023-17042
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103197303
• UDI-Public: (01)00690103197303(17)250817(11)230818(10)65236657A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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 Model Number: 782F75M
• Device Lot Number: 65236657A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 07/18/2024
• Supplement Dates FDA Received: 11/08/2023; 07/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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