MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PUERTO RICO SWAN-GANZ TRUE SIZE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	120602F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dyg- catheter, flow directed.Dqe- catheter, oximeter, fiberoptic.Kra- catheter, continuous flush.The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming when the results become available.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.This mdr is associated with mw 61143.
Event or Problem Description
As reported, during an emergency thrombectomy on the left lower extremity, the balloon broke on the 2fr fogarty thrombectomy catheter.The scrub tech tested the catheter balloon with the appropriate amount of fluid before handing to the surgeon to use.In the physician's attempt to perform the thrombectomy, as they inflated the balloon and attempted to remove it from patient's extremity, the balloon of the catheter detached and remains stuck inside the patient.Per the customer, this occurred twice during the case.There was no allegation of patient injury.Attempts for additional information have been made however no further information is available at this time.Device is expected to return.
Additional Manufacturer Narrative
A correction was made to section h10.Related report numbers.
Additional Manufacturer Narrative
Correction made to section h10 related report numbers.
Additional Manufacturer Narrative
No product was returned 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.As part of the manufacturing process 100% of the units go through a balloon winding and visual inspection process.As a warning the ifu states that balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.The device history record review was completed and all manufacturing inspections passed with no non conformances.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 part of the monthly review.

• Brand Name: SWAN-GANZ TRUE SIZE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PUERTO RICO; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 21380603
• Report Number: 2015691-2025-01034
• Device Sequence Number: 8595863
• Product Code: DQO
• UDI-Device Identifier: 00690103043273
• UDI-Public: (01)00690103043273(17)260812(11)240513(10)65746748
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/21/2025

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: 08/12/2026
• Device Model Number: 120602F
• Device Lot Number: 65746748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 03/11/2025; 03/11/2025; 03/18/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/13/2025; 03/14/2025; 03/17/2025; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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: Prefer Not To Disclose