FDA Adverse Event Malfunction Summary report: N

HEARTSTRING PROXIMAL SEAL 4.3 MM

MDR report key: 1701630 · Received May 19, 2010

Report

Report Number: 2648729-2010-01438
Event Type: Malfunction
Date Received: May 19, 2010
Report Date: April 19, 2010
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: DXC
PMA / PMN Number: K022880
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON MAY 10, 2010, FOR INVESTIGATION. THE VISUAL INSPECTION REVEALED THAT THE HEARTSTRING II DELIVERY DEVICE WAS RECEIVED WITH THE SEAL AND TENSION SPRINGS INTACT AND OUTSIDE THE DELIVERY TUBE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS WHERE THE SEAL WAS OUTSIDE THE DELIVERY TUBE AND THERE WERE NO SIGNS OF BLOOD, THE REPORTED FAILURE CANNOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS PERFORMED FOR ALL OF THE POSSIBLE LOT NUMBERS. NONE OF THE REPORTED LOTS HAD ANY NONCONFORMITIES THAT COULD HAVE CAUSED THE REPORTED FAILURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

Description of Event or Problem · 1

THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING II SEAL DID NOT PLACE INTO THE PROPER POSITION, AS IT WOULD NOT DEPLOY OUT OF THE DELIVERY TUBE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED. THREE LOT NUMBERS WERE REPORTED AS POTENTIALLY BEING THE LOT NUMBER FOR THE REPORTED DEVICE: 9032073, 9033171, AND 9060471.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEARTSTRING PROXIMAL SEAL 4.3 MM	PROXIMAL SEAL	DXC	MAQUET CARDIOVASCULAR, LLC	HSK-2043	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA