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

Model Number H749518080

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2014.It was reported that during the procedure, kink occurred.The opticross¿ imaging catheter was inserted into the patient and used to observe the lesion but the distal tip of the imaging catheter got kink.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 a open hole in the sheath lap joint section of the catheter.

Manufacturer Narrative

Age at 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 a kink was observed in the sheath assembly at 72.5 cm from femoral marker at the distal end.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.An open hole was observed at the sheath lap joint section of the device.Fluid was leaking from the open hole at the sheath lap joint assembly when the catheter was flushed.Impedance testing finds the device is capable of imaging properly.Full image characterization testing cannot be performed based on the returned condition of the catheter.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: 3941693
• MDR Text Key: 4574110
• Report Number: 2134265-2014-04237
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2014

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: 03/13/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16815305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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