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 02/07/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that the distal tip of the device got kink.The opticross imaging catheter was used to visualize the unspecified lesion.It was noted that during percutaneous coronary intervention, the distal tip of the device got kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.However, returned device analysis revealed an open hole at the sheath lap joint assembly.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received with an open hole at the sheath lap joint assembly.Fluid leaking from an open hole at the sheath lap joint assembly when the catheter was flushed.A kink was observed in the imaging window assembly at 67.1 cm from femoral marker at the proximal end.The telescope assembly was not able to properly pull back, advance, or retract.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 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: 3883495
• MDR Text Key: 4426775
• Report Number: 2134265-2014-03424
• 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: 05/22/2014

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: 11/11/2014
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 16527427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/19/2014
• 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