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 09/24/2014

Event Type  malfunction  

Event Description

Reportable based on the investigation completed on (b)(4) 2014.It was reported that a kink in the telescope was noted.During a procedure, an opticross¿ imaging catheter was used in order to visualize the unspecified target lesion.However, a kink in the telescope section of the device was then observed.The device was then exchanged with another of the same device in order to complete the procedure.No patient complications were reported and the patient's condition is good.However, returned device analysis revealed an open hole at the sheath lap joint section of the device.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.After device analysis, no kinks were observed along the length of the catheter.The telescope assembly was not able to properly pull back, advance, and retract.The telescope cannot advance the transducer distal housing (tdh) to the most distal position, the distance from the distal end of the transducer housing to the tip of the catheter was not measured.Fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing.During image characterization testing, no image appeared in the system due to electrical open at proximal.Imaging core windup was found in the telescope assembly.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(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: 4274710
• MDR Text Key: 17935178
• Report Number: 2134265-2014-07175
• 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: 11/03/2014

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: 07/15/2015
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17123884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2014
• 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