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

Model Number H749518080

Device Problems Fluid/Blood Leak (1250); Flushing Problem (1252); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2015.It was reported that imaging catheter leak, kink and inability to flush occurred.During procedure, an opticross¿ imaging catheter was selected to view the severely tortuous target lesion which was obtained via femoral artery.After the opticross¿ was delivered a few times, it was then flushed outside the patient.However, it was noted that the saline leaked from a part of the shaft.It was further noted that the device was kinked.Subsequently, the device became unable to flush.The procedure was completed with another of the same device.No patient complications were reported.The patient's status was good.However, device analysis revealed a lap joint partial separation.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for evaluation.Evaluation of the returned device revealed a kink in the sheath (lap joint section) at 73cm from the femoral marker to the distal end and a lap joint partial separation in the device.The telescope assembly was not able to properly pull back, advance, or retract due to the lap joint partial separation.During flushing, fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing.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: 4754031
• MDR Text Key: 5769118
• Report Number: 2134265-2015-02653
• 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: 04/13/2015

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: 12/10/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17531002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2014
• 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