MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) OPTICROSS?; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problems No Display/Image (1183); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that lost image and tip kinked occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified middle of left anterior descending(lad) artery.During the percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to view the lesion.The intravenous ultrasound was then performed subsequent to stenting.Strong resistance was encountered at proximal lad.And then, lost image occurred near the proximal side of the unspecified stent.After that, this opticross¿ was removed outside the patient.It was then reported that the distal tip of the opticross¿ was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed a sheath assembly was found to have the clear imaging window tubing detached from the blue sheath tubing at the lap joint.

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that a kink was found on the distal tip.The sheath assembly was found to have the clear imaging window tubing detached from the blue sheath tubing at the lap joint.This fully exposes the imaging core.Fluid was leaking from the detached section when the catheter was flushed.The telescope assembly was not able to properly pull back, advance, or retract due to the condition of the device.Since the telescope cannot advance the transducer distal housing (tdh) to the most distal position, the distance from the distal end of the transducer housing to the tip of the catheter was not measured.Impedance testing finds that there was no electrical disconnect in the imaging circuit.Full image characterization cannot be performed due to the imaging window detached from the blue sheath tubing at the lap joint seam.The detachment exposes the imaging core which might onset a windup of the imaging core when a functional test is performed.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).

• Brand Name: OPTICROSS?
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3894581
• MDR Text Key: 4648589
• Report Number: 2134265-2014-03760
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• PMA/PMN Number: K123621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16724009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1