MAUDE Adverse Event Report: BALT USA CARRIER DELIVERY CATHETER

Model Number	CR7074
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/27/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Balt usa reference: #(b)(4).An evaluation of the actual complaint sample could not be performed as device was unavailable to be return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f251000709 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "text received from the physician "had vessel rupture with raptor/carrier last night.I don't think it was device related.Pulled out a long firm clot on 6th pass and had extrav from m1 probably avulsed m2 pt died"" update 28jan2026 - additional information received from the issuer: "passing along this complaint.I do not yet have specific reference numbers or lots; will forward when they become available.Wanted to document because patient death was reported.Physician does not believe this was a device related injury.".

• Brand Name: CARRIER DELIVERY CATHETER
• Common Device Name: CARRIER
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: david vu ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 24475681
• Report Number: 3014162263-2026-00006
• Device Sequence Number: 9615516
• Product Code: QJP
• UDI-Device Identifier: 00810068561982
• UDI-Public: (01)00810068561982(11)251018(17)261018(10)F251000709
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K252569
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CR7074
• Device Lot Number: F251000709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown