FDA Adverse Event Malfunction Summary report: N

TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES

MDR report key: 24066288 · Received January 14, 2026

Report

Report Number: 2248146-2026-0000289
Event Type: Malfunction
Date Received: January 14, 2026
Date of Event: December 22, 2025
Report Date: February 23, 2026
Manufacturer: DATASCOPE CORP.
Product Code: DSP
UDI-DI: 10607567111728
PMA / PMN Number: K122628
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DUE TO CHARACTER LIMIT: E.1. EVENT SITE NAME: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID (B)(4).

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, D1, D4 (VERSION OR MODEL, CATALOG, LOT, EXP DATE AND UDI), D9, G3, G4 (PMA/510K), G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. THE ISSUE WAS RESOLVED BY SWITCHING MONITORING FROM THE TRANSRAYPLUS OPTICAL SENSOR TO A PRESSURE TRANSDUCER, AFTER WHICH A NORMAL ARTERIAL WAVEFORM WAS DISPLAYED AND TREATMENT CONTINUED WITH NO IMPACT ON THE PATIENT.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING TRANSRAYPLUS INTRA-AORTIC BALLOON (IAB) USING AN OPTICAL SENSOR WITH CARDIOSAVE, NOISE APPEARED IN THE ARTERIAL WAVEFORM AND WAS UNABLE TO MONITOR THE ARTERIAL WAVEFORM. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

Description of Event or Problem · 0

N/A.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
125949	TRANS-RAY PLUS 7.5FR 40CC IAB WITH ACCESSORIES	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL	DSP	DATASCOPE CORP.	0684-00-0608	0684-00-0608	10607567111728

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		CARDIOSAVE.