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

Model Number H749518080

Device Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 03feb2015.I was reported that poor image and error message were displayed.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified middle left anterior descending (lad) artery.During percutaneous coronary intervention (pci), an opticross¿ imaging catheter was used to view the lession.Upon pre- intravenous ultrasound (ivus), it was noted that the image became dark and a "catheter connect" error message was displayed on the screen.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 foreign matter in the ccp board.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The complaint device was received for evaluation.Evaluation of the returned device revealed a kink in the sheath assembly at 4.5 cm from the distal femoral marker to the distal end.Foreign matter encountered in the ccp board.Impedance testing shows a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.The telescope assembly was able to properly pull back, advance, and retract.The unit was correctly recognized by the imaging system when plugged into the mdu during functional testing.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: 4552422
• MDR Text Key: 5523817
• Report Number: 2134265-2015-00929
• 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: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17316865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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