FDA Adverse Event Malfunction Summary report: N

OPTICROSS?

MDR report key: 3883886 · Received June 19, 2014

Report

Report Number: 2134265-2014-03447
Event Type: Malfunction
Date Received: June 19, 2014
Report Date: May 22, 2014
Manufacturer: BOSTON SCIENTIFIC - FREMONT (SUD)
Product Code: OBJ
PMA / PMN Number: K123621
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED WITH FLUID LEAKING FROM AN OPEN HOLE AT THE SHEATH LAP JOINT AREA WHEN THE CATHETER WAS FLUSHED. A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY AT 72.5 CM FROM FEMORAL MARKER AT THE DISTAL END. THE TELESCOPE ASSEMBLY WAS NOT ABLE TO PROPERLY PULL BACK, ADVANCE, OR RETRACT. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER, HOWEVER DURING IMPEDANCE TESTING, ELECTRICAL OPEN AT DISTAL WAS OBSERVED. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

Description of Event or Problem · 1

REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT A SHEATH LEAK OCCURRED. THE OPTICROSS IMAGING CATHETER WAS RETURNED AS AN EXTRA CATHETER. UPON PRELIMINARY INSPECTION OF THE RETURNED DEVICE, LEAKING OF THE LAP JOINT WAS FOUND. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN OPEN HOLE AT THE SHEATH LAP JOINT ASSEMBLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361175	OPTICROSS?	CATHETER, ULTRASOUND, INTRAVASCULAR	OBJ	BOSTON SCIENTIFIC - FREMONT (SUD)	H749518080	16565436

Patients

Seq	Age	Sex	Outcome	Treatment
1