MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY SOFTJAW; CLAMP, VASCULAR

Model Number	CSOFT6
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.A supplemental report will be forthcoming when the investigation is 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.
Event or Problem Description
It was reported that upon opening pouch prior to use on patient, dirt on this fogarty spring clips was found.There was no allegation of patient injury.

• Brand Name: FOGARTY SOFTJAW
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km; 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 17200 laguna canyon, rd; irvine, CA 92618 ; 9492017706
• MDR Report Key: 25257840
• Report Number: 2015691-2026-15465
• Device Sequence Number: 5495769
• Product Code: DXC
• UDI-Device Identifier: 00690103044195
• UDI-Public: (01)00690103044195(17)271202(11)241202(10)66186398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K832554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 Model Number: CSOFT6
• Device Lot Number: 66186398
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown