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

Model Number H749518080

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that resistance and catheter shaft kink were encountered.The opticross¿ imaging catheter was used to visualize an unspecified lesion with moderate tortuosity.It was noted that after performing pullback, physician attempted to insert this device into the vessel but encountered severe resistance near the telescope leading to kink in the proximal portion of the catheter.However, returned device analysis revealed a hole/perforation in the sheath of the imaging widow.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the complaint device was received with fluid 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.Leak is located on the outside edge of the device.A kink was observed in the telescope assembly at 70.5 cm from femoral marker at the proximal end and in the sheath assembly at 16.2 cm from femoral marker at the proximal end.During image characterization testing, no image appeared in the system due to electrical open at proximal.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 considered handling damage as the event occurred without direct patient contact.(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: 3826668
• MDR Text Key: 4501760
• Report Number: 2134265-2014-02758
• 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: 04/25/2014

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: 10/23/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16480623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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