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

Model Number H749518080

Device Problems No Display/Image (1183); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

Reportable based on investigation completed on (b)(4) 2015.It was reported that a telescope resistance was encountered and lost image occurred.During percutaneous coronary imaging (pci), an opticross¿ imaging catheter was used to visualize an unspecified lesion.However, resistance was encountered when the telescope was pulled back to its initial position and subsequently, lost image occurred.The procedure was completed using a different device.No patient complications were reported and the patient¿s status is good.However, returned device analysis revealed of an open hole at the lap joint section of the device.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that an open hole was observed at lap joint section of the device at 73cm from the femoral marker to the distal end.Fluid was leaking from the open hole at the sheath lap joint junction between the blue sheaths and clear imaging window tubing when the catheter was flushed.Kinks were observed in the telescope assembly at 71.4 cm and at 73.7 cm from femoral marker to the proximal end.The telescope assembly was not able to properly pull back, advance, or retract due to the lap joint partial separation and kinks in the telescope.Impedance testing shows an electrical open at proximal wave form.Based on the x-ray images, the electrical failure was a result of a broken coax cable.Full image characterization cannot be performed due to the open hole in the lap joint.Imaging core windup was not found within the telescope section of the 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: 4753626
• MDR Text Key: 5785396
• Report Number: 2134265-2015-02719
• 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: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17600000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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