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

Model Number H749518080

Device Problems Device-Device Incompatibility (2919); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

It was reported that a foreign matter was found.The target lesion was located in the moderately calcified vessel.During the percutaneous cardiovascular intervention, the opticross¿ imaging catheter was used however peripheral view was displayed on the screen.Reconnection was performed several times but the issue was not resolved.The device was checked upon removal and a white jelly-like object was seen at the connector.The procedure was completed another with same device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for evaluation.Device analysis revealed that a foreign matter encountered in the ccp board.The unit was able to connect into motordrive unit (mdu) system properly.The catheter was properly recognized by the imaging system when plugged into the mdu and not connection issues or errors were detected during its testing.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).

Event Description

It was reported that a foreign matter was found.The target lesion was located in the moderately calcified vessel.During the percutaneous cardiovascular intervention, the opticross¿ imaging catheter was used however peripheral view was displayed on the screen.Reconnection was performed several times but the issue was not resolved.The device was checked upon removal and a white jelly-like object was seen at the connector.The procedure was completed another with same device.No patient complications were reported and the patient's condition was good.

• 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: 4884868
• MDR Text Key: 18882246
• Report Number: 2134265-2015-04115
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17849591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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