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

Model Number H749518080

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that the telescope did not move back to its original position.The opticross imaging catheter was used to visualize an unspecified lesion.It was noted during percutaneous coronary intervention, the telescope did not move back to its original position after pullback.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition is good.However, returned device analysis revealed an open hole at the lap joint area.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received with a kink observed in the imaging window assembly at 67.1 cm from femoral marker at the proximal end.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 pullback or advance.Impedance testing finds that there was no electrical disconnect in the imaging circuit.Full image characterization cannot be performed due to the imaging window detached from the blue sheath tubing at the lap joint seam.The imaging core (ic) or drive shaft was found to have broken off from the rotating hub shaft connector.Windup of the ic was found within the telescope section of the device.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: 3876237
• MDR Text Key: 4591471
• Report Number: 2134265-2014-03417
• 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: 05/19/2014

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: 11/12/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16529386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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