FDA Adverse Event Malfunction Summary report: N

FAST-CATH HEMOSTASIS INTRODUCER 8F, 12CM SHEATH

MDR report key: 1002805 · Received February 26, 2008

Report

Report Number: 2182269-2008-00062
Event Type: Malfunction
Date Received: February 26, 2008
Date of Event: January 31, 2008
Report Date: February 2, 2008
Manufacturer: ST. JUDE MEDICAL
Product Code: DYB
PMA / PMN Number: K870374
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. EVEN THOUGH NO PRODUCT WAS RETURNED FOR EVAL, INTERNAL CORRECTIVE ACTIONS WERE IMPLEMENTED TO ADDRESS THE SOLVENT APPLICATION DURING THE MFG PROCESS. OPERATOR RETRAINING AND AWARENESS DOCUMENTED THE EFFECTS OF SIDE PORT DETACHMENT, AS WELL AS, THE TOLERANCES OF THE SIDE PORT AND TUBING.

Description of Event or Problem · 1

THE PROBLEM WAS THAT, POST PROCEDURE, THE SIDEARM DETACHED FROM THE SHEATH HUB. THIS LED TO BLEEDING OUT OF THE SIDEARM AND THE INTRODUCER NEEDED TO BE REPLACED WITH ANOTHER ONE. THE SEPARATION OF TUBING APPEARED TO SIMPLY BE THAT THE BONDING AGENT ON THE TUBE WHERE IT CONNECTS WITH THE SHEATH HUB WAS NOT SUFFICIENT TO STAY IN PLACE AND/OR THERE WAS EXCESSIVE TUGGING ON THE TUBING TO CREATE THE SEPARATION. THIS EVENT OCCURRED WITH ANOTHER PT JUST A COUPLE OF DAYS FROM THIS ONE WITH THE SAME LOT NUMBER. NEITHER EVENT CAUSED ANY PROBLEMS FOR THE PT. THE ACCOUNT STATED THERE WAS NO EXCESSIVE PULLING ON THE SIDEARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FAST-CATH HEMOSTASIS INTRODUCER 8F, 12CM SHEATH	FAST-CATH 8F, 12CM	DYB	ST. JUDE MEDICAL	NA	2034808

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention