FDA Adverse Event Malfunction Summary report: N

LINEAR 7.5 FR. 34CC IAB

MDR report key: 17312855 · Received July 12, 2023

Report

Report Number: 2248146-2023-00436
Event Type: Malfunction
Date Received: July 12, 2023
Date of Event: June 4, 2023
Report Date: August 30, 2023
Manufacturer: DATASCOPE CORP. - FAIRFIELD
Product Code: DSP
UDI-DI: 10607567106557
PMA / PMN Number: K041281
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MY
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT #(B)(4).

Additional Manufacturer Narrative · 0

EVENT SITE FULL ADDRESS: (B)(6), EVENT SITE POSTAL CODE: (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 # 841786 H3 OTHER TEXT : DEVICE NOT RETURNED.

Description of Event or Problem · 0

N/A

Description of Event or Problem · 0

IT WAS REPORTED DURING INSERTION,THE CUSTOMER WAS UNABLE TO INSERT THE INTRA-AORTIC BALLOON (IAB) INTO THE ARTERIAL SITE WITH A SHEATH-LESS TECHNIQUE. THE IAB WAS REMOVED. THERE WAS A SECOND ATTEMPT AT INSERTION, BUT IT FAILED AND WAS REMOVED. THE SCRUB NURSE NOTED BLOOD HAD ENTERED THE IAB CATHETER MEMBRANE, WHICH WAS NOT CONNECTED TO THE PUMP. A NEW IAB WAS INSERTED ON THE FEMORAL ARTERY LINE SUCCESSFULLY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
241145	LINEAR 7.5 FR. 34CC IAB	SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL	DSP	DATASCOPE CORP. - FAIRFIELD	0684-00-0479-01	3000127285	10607567106557

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR	Female