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

Model Number H749518080

Device Problems No Display/Image (1183); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that lost image and inability to reposition telescope occurred.The 85% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal and distal of right coronary artery (rca).During the percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to view the lesion.The opticross¿ was advanced to the distal of rca and auto pullback was performed.Image appeared without any issues until the pullback was finished.After that, the physician tried to reposition the telescope but he/she couldn't reposition it despite several attempts.The physician tried to perform imaging again, but the monitor display turns black.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 hole at the lap joint area of the catheter.

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed that fluid was found leaking from an open hole at the lap joint area when the catheter was flushed.The imaging window was still connected to the blue sheath tubing at the lap joint.The telescope assembly was not able to properly pull back, advance, or retract.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.During image characterization testing, no image appeared in the system due to electrical open at proximal.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray images, the electrical failure was a result of a broken coax cable.Imaging core wind up in the telescope assembly was observed during x-ray analysis.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 is operational context as device performance was limited due to anatomical procedural factors.(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: 3868339
• MDR Text Key: 4509161
• Report Number: 2134265-2014-03289
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16585565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• 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