FDA Adverse Event Malfunction Summary report: N

HS III PROXIMAL SEAL

MDR report key: 3031041 · Received March 28, 2013

Report

Report Number: 2242352-2013-00292
Event Type: Malfunction
Date Received: March 28, 2013
Date of Event: March 7, 2013
Report Date: March 7, 2013
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: GEI
PMA / PMN Number: K080169
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS NOT RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND SEAL WERE INSIDE THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. IT APPEARS THAT THE SEAL HAD BEEN PREMATURELY DEPLOYED. AS STATED IN THE IFU, THE USER SHOULD ENSURE THAT THE LOCK IS LOCKED. IF THE LOCK IS UNLOCKED, CARE SHOULD BE TAKEN TO AVOID ANY ACCIDENTAL DEPRESSING OF THE PLUNGER. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; HOWEVER, IT WAS CONFIRMED FOR PREMATURE DEPLOYMENT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

Description of Event or Problem · 1

THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL FAILED TO LOAD PROPERLY AS IT REMAINED INSIDE OF THE LOADING DEVICE UPON REMOVING THE DELIVERY DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
129530	HS III PROXIMAL SEAL	CLAMPLESS BEATING HEART	GEI	MAQUET CARDIOVASCULAR, LLC	HS-3045	25067371

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA