VISTA BRITE TIP GUIDING CATHETERS

Report

Report Number: 9616099-2013-00004
Event Type: Malfunction
Date Received: January 3, 2013
Date of Event: December 13, 2012
Report Date: December 13, 2012
Manufacturer: CORDIS DE MEXICO
Product Code: DQY
PMA / PMN Number: K972978
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT DEVICES: INFLATION DEVICE: B BRAUN'S; GW: ASAHI INTECH'S; GC: BRITE TIP JR4, AL1; YCONNECTOR: OKAY; BC: TREK2.5/20MM, 3/20MM; SHEATH: MEDIKIT'S; STENT: XIENCE PRIME.

Additional Manufacturer Narrative · 1

INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT WHEN 7FR JR4 BRITE TIP GUIDING CATHETER WAS RETRIEVED FROM THE PATIENT, THE PHYSICIAN CONFIRMED A CRACK (2 MM LONG) AT THE DISTAL TIP. THE PATIENT WAS A (B)(6) MALE. THE PATIENT WAS UNDERGOING STENTING OF THE MID RIGHT CORONARY ARTERY. THE LESION WAS A DE NOVO, MODERATELY CALCIFIED, AND MODERATELY TORTUOUS. THERE WAS 99% STENOSIS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. WHEN THE BRITE TIP (7F JR4: COMPLAINT PRODUCT) WAS BEING INSERTED INTO THE PATIENT, OVER AN ASAHI INTEC'S GW, THE PHYSICIAN FELT SOMETHING UNUSUAL. THE ACCESS SITE LOCATION IS UNKNOWN. THEN, THE BRITE TIP WAS RETRIEVED FROM THE PATIENT, AND THE PHYSICIAN CONFIRMED A CRACK (2 MM LONG) AT THE DISTAL TIP. THERE WAS NO EXCESSIVE FORCE USED TO INSERT THE DEVICE INTO THE PATIENT. THE TIP OF THE DEVICE DID NOT PROLAPSE ON ITSELF. THEREFORE, THE PHYSICIAN DID NOT USE THE BRITE TIP AND A NEW BRITE TIP (SAME SHAPE) WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY REPORTED AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS NOT INDICATED IT CATHETER GOT CAUGHT AT ANY TIME OR IF THERE WAS DIFFICULTY ADVANCING THE DEVICE OVER THE WIRE OR THROUGH THE SHEATH. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT AND REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF DISTAL TIP OF GUIDING CATHETER CRACKED COULD NOT BE CONFIRMED. SINCE THE DEVICE APPEARED NORMAL PRIOR TO INSERTING INTO THE PATIENT THERE MAY HAVE BEEN DEVICE INTERACTION EITHER WITH THE SHEATH OR THE GUIDEWIRE THAT CONTRIBUTED TO THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. THERE IS NOTHING IN THE EVENT DESCRIPTION OR THE DEVICE HISTORY REPORT REVIEW TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

Description of Event or Problem · 1

AS REPORTED, WHEN THE BRITE TIP WAS RETRIEVED FROM THE PATIENT, THE PHYSICIAN CONFIRMED A CRACK (2MM LONG) AT THE DISTAL TIP. THE PATIENT WAS A (B)(6) MALE. THE PATIENT WAS UNDERGOING STENTING OF THE MID RIGHT CORONARY ARTERY. THE LESION WAS A DE NOVO, MODERATELY CALCIFIED, AND MODERATELY TORTUOUS. THERE WAS 99% STENOSIS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. WHEN THE BRITE TIP (7F JR4: COMPLAINT PRODUCT) WAS BEING INSERTED INTO THE PATIENT, OVER AN ASAHI INTEC'S GW, THE PHYSICIAN FELT SOMETHING UNUSUAL. THE ACCESS SITE LOCATION IS UNKNOWN. THEN, THE BRITE TIP WAS RETRIEVED FROM THE PATIENT, AND THE PHYSICIAN CONFIRMED A CRACK (2MM LONG) AT THE DISTAL TIP. THERE WAS NO EXCESSIVE FORCE USED TO INSERT THE DEVICE INTO THE PATIENT. THE TIP OF THE DEVICE DID NOT PROLAPSE ON ITSELF. THEREFORE, THE PHYSICIAN DID NOT USE THE BRITE TIP AND A NEW BRITE TIP (SAME SHAPE) WAS USED INSTEAD. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
3498	VISTA BRITE TIP GUIDING CATHETERS	CARDIOLOGY GUIDING CATHETERS (DQY)	DQY	CORDIS DE MEXICO	NA	15642889

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR