FDA Adverse Event Injury Summary report: N

ENDO-SOF DOUBLE PIGTAIL STENT SET MULTI-LENGTH

MDR report key: 926884 · Received October 10, 2007

Report

Report Number: 1825146-2007-00020
Event Type: Injury
Date Received: October 10, 2007
Manufacturer: COOK UROLOGICAL
Product Code: FAD
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A PROPER EVALUATION CANNOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED. ACCORDING TO THE CUSTOMER'S STATEMENT, THE PHYSICIAN FAILED TO REMOVE ALL OF THE TETHER UPON REMOVAL OF THE PRODUCT FROM THE PT LEAVING IT INDWELL FOR 2 YEARS. CUSTOMER USE ERROR HAS CAUSE THIS TO OCCUR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

Description of Event or Problem · 1

CUSTOMER STATES: "DR REPORTED THAT HE EXPERIENCED DIFFICULTY WITH REMOVING THE TETHER ON MLSCS-070022-32-AQ WHEN PLACING STENTS PERCUTANEOUSLY. DR STATED THAT DURING 2005 AND 2006 WHILE PLACING THESE PARTICULAR STENTS PERCUTANEOUSLY, HE HAD CUT TETHER OFF AT SKIN LEVEL AND LEFT TETHER INDWELLING. HE REPORTED THAT A PT HAD RECENTLY PRESENTED WITH MULTIPLE CALCULI FORMED AROUND A TETHER THAT HAD REMAINED INDWELLING FOR A PERIOD OF TWO YEARS. DR STATED THAT THE ENDO-SOF STENT HAD PREVIOUSLY BEEN REMOVED AND ANOTHER STENT INSERTED AND THAT THE TETHER FROM THE ORIGINAL ENDO-SOF STENT HAD BEEN LEFT INDWELLING. DR STATED THAT THE TETHER AND CALCULI HAD RECENTLY BEEN REMOVED FROM THE PT'S KIDNEY AND DR SHOWED A JAR CONTAINING THE CALCULI (WHICH APPEARED TO SURROUND THE TETHER). DR STATED THAT DURING 2007, HE HAS BEEN REMOVING THE TETHER FROM ENDO-SOF STENTS PRIOR TO PLACING THEM PERCUTANEOUSLY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDO-SOF DOUBLE PIGTAIL STENT SET MULTI-LENGTH	URETERAL PIGTAIL STENT	FAD	COOK UROLOGICAL	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Other