MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR TRUWAVE, VAMP; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVMP260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: kra- catheter, continuous flush.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 during use of the truwave, the patient experienced arterial vasospasm.They attempted to draw slower without success.They ultimately drew waste and blood from the needless access port successfully.Subsequently, they observed significant vasospasm of the artery.Finally, when attempting to use the pull tab to flush the line the tab broke off.There was no patient injury.
Additional Manufacturer Narrative
One single dpt - vamp adult kit was returned for evaluation.Dry blood was visible on the sample sites.The customer report of flush tab broke off was confirmed.As received snap-tab of dpt flush device had been completely broken at the bottom of the poppet.Broken snap-tab was not returned.Cross surface at the site of damage appeared rough and uneven.Report of unable to draw back with vamp was not able to be confirmed.Pressure line was able to be primed and flushed from dpt vent port without any occlusion or flow restriction.Vamp adult system functioned properly.Plunger of vamp system was able to move without any problem.No other visible damage was observed from returned kit.The device history record review was not completed as the lot number was not provided.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information, there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.As part of the manufacturing process, 100% of the units undergo a leak test and visual inspection.

• Brand Name: TRUWAVE, VAMP
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): BD APM; 17200 laguna canyon rd; irvine CA 92618
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 23785790
• Report Number: 2015691-2025-09958
• Device Sequence Number: 21450058
• Product Code: DXO
• UDI-Device Identifier: 07460691950535
• UDI-Public: 07460691950535
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: PXVMP260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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