MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ TRUE SIZE THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number	096F6P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a swan ganz balloon dislodged from the catheter during a procedure in the cath lab.The patient was admitted and being catheterized for further diagnosis and treatment of chronic systolic heart failure.Upon first pass into the heart, the balloon was inflated and wedged.The balloon was visible under fluoroscopy.The catheter was then removed and reinserted for a second pass.Upon attempting to inflate and wedge, no balloon was visible under fluoroscopy after second insertion.The catheter was removed and there was no visible balloon.Per hospital report, there were no visible evidence of foreign material in patient vasculature at any point during the procedure, which lead the staff to believe the piece of balloon was caught in the sheath.The patient did not have any adverse event or injury related to the procedure and remained hospitalized for further care as the patient required a pacemaker.The sales rep was able to observe the swan and it appeared as if the balloon was completely sheared off.There were no fragments remaining on the catheter.Information of the introducer brand or size was unknown.
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation.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
Per follow up with customer, risk management at the hospital refused to return catheter to edwards.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.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.

• Brand Name: SWAN GANZ TRUE SIZE THERMODILUTION CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• 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: 17770256
• Report Number: 2015691-2023-16025
• Device Sequence Number: 17946866
• Product Code: DYG
• UDI-Device Identifier: 00690103000245
• UDI-Public: (01)00690103000245(17)250501(11)230502(10)65023541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K810124
• 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
• Report Date (Section B): 09/27/2023

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
• Device Expiration Date: 05/01/2025
• Device Model Number: 096F6P
• Device Lot Number: 65023541
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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