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

Model Number H749518080

Device Problems No Display/Image (1183); Fluid/Blood Leak (1250); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on (b)(4) 2014.It was reported that a resistance , lost image, and catheter leak occurred during the procedure.The target lesion with a very small vessel diameter was located in the left anterior descending artery (lad).During a percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used however a little resistance was encountered upon the insertion of the device.The physician suspected that the device might be kinked but still performed the pullback.During the 1st pullback, the image was lost.The device was flushed and mdu was reconnected, but still the issue was not solved.The physician noticed then a saline leak from the middle of the catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition is good.However, device analysis revealed an open hole at the sheath lap joint section of the device.

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the complaint device was received for evaluation.Evaluation of the returned device revealed that the telescope assembly was not able to properly pull back, advance and retract.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.Fluid was leaking from the open hole at the sheath lap joint assembly when the catheter was flushed.The imaging window is still connected to the blue sheath at the lap joint.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.During image characterization testing, no image appeared in the system due to electrical open at distal.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 positive lead disconnect from the face of the transducer.No wind up was observed on the imaging core 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 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4146999
• MDR Text Key: 4767275
• Report Number: 2134265-2014-06041
• 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: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17069172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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