FDA Adverse Event Injury Summary report: N

COOL PATH DUO 7F, 1304-CP2-7-1.5 (5)- L1-TE4BE1AB

MDR report key: 1970279 · Received January 14, 2011

Report

Report Number: 2030404-2011-00015
Event Type: Injury
Date Received: January 14, 2011
Date of Event: December 20, 2010
Report Date: December 20, 2010
Manufacturer: ST. JUDE MEDICAL, IRVINE
Product Code: OAD
PMA / PMN Number: P060019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED PERFORATION REMAINS UNK. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 11/14/2011. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4)2010.

Description of Event or Problem · 1

IT WAS REPORTED WHEN THE PHYSICIAN PERFORMED THE TRANSSEPTAL PUNCTURE, THE PERICARDIUM WAS PERFORATED WITH THE TRANSSEPTAL NEEDLE. THE PHYSICIAN PROCEEDED WITH A SECOND TRANSSEPTAL PUNCTURE WITHOUT DIFFICULTY AND DECIDED TO CONTINUE THE PROCEDURE. WHEN THE COOL PATH DUO CATHETER WAS INSERTED INTO THE LEFT ATRIUM, IT WENT THROUGH THE HOLE CREATED BY THE FIRST PUNCTURE WITH THE TRANSSEPTAL NEEDLE AND A CARDIAC TAMPONADE OCCURRED. IT WAS NOTED THERE WAS AN ANEURYSM PRESENT WHICH MIGHT HAVE WEAKENED THE CARDIAC WALL AND CAUSED THE EFFUSION. TO RESOLVE THE TAMPONADE, A SURGEON MADE A THORACOTOMY INCISION AND SUTURED THE LEFT ATRIA. THE PHYSICIAN DID NOT IMPLICATE THE CATHETER AS THE CAUSE FOR THE TAMPONADE AS THE PERFORATION OCCURRED BEFORE THE COOL PATH DUO CATHETER WAS INSERTED INTO THE LEFT ATRIA. NO OTHER COMPLICATIONS OCCURRED FOR THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COOL PATH DUO 7F, 1304-CP2-7-1.5 (5)- L1-TE4BE1AB	NONE	OAD	ST. JUDE MEDICAL, IRVINE	83565	3175315

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK