FDA Adverse Event Death Summary report: N

LINEAR 7.5 FR. 34CC IAB

MDR report key: 3946228 · Received July 2, 2014

Report

Report Number: 2248146-2014-00188
Event Type: Death
Date Received: July 2, 2014
Date of Event: March 5, 2012
Report Date: March 10, 2012
Manufacturer: DATASCOPE CORP.
Product Code: DSP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT CONDITION RECEIVED: THE PRODUCT WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE INTERIOR AND EXTERIOR OF THE CATHETER AND BETWEEN THE CATHETER AND THE SHEATH. THE RETURNED SHEATH WAS OVER THE CATHETER AND PARTIALLY COVERING THE REAR PORTION OF THE BALLOON. THE EXTRACORPOREAL TUBING WAS NOT RETURNED. PRODUCT EVALUATION: AN UNDERWATER LEAK TEST OF THE BALLOON, CATHETER AND Y-FITTING WAS PERFORMED AND ONE LEAK WAS DETECTED ON THE MEMBRANE APPROXIMATELY 1.5CM FROM THE REAR SEAL MEASURING 0.025CM IN LENGTH. CONCLUSION: UNDER MAGNIFICATION, A WHITISH PATCH WAS OBSERVED AROUND THE LEAK. THIS WHITISH PATCH IS THE TYPICAL APPEARANCE OF AN ABRASION MARK WHICH IS CAUSED BY CALCIFIED PLAQUE IN THE AORTA. THE MEMBRANE PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CONTACT WITH CALCIFIED PLAQUE DURING COUNTERPULSATION THERAPY. A REVIEW OF THE DEVICE HISTORY DOES NOT INDICATE ANY LOT SPECIFIC ISSUES. (B)(4).

Description of Event or Problem · 1

(B)(6) HOSPITAL HAD A RUPTURED IAB AND WANTED A RETURN KIT TO SEND IT BACK. IT WAS REPLACED, NO PATIENT INJURY REPORTED. DATA-SHEET REPORTED: BLOOD NOTED IN BALLOON CATHETER. M.D. NOTIFIED STAT. BALLOON REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
385334	LINEAR 7.5 FR. 34CC IAB	INTRA-AORTIC BALLOON	DSP	DATASCOPE CORP.	0684-00-0474	2667

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Death