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

Model Number H749518080

Device Problems No Display/Image (1183); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device returned to mfr: the device was returned for evaluation.Device analysis revealed that there is an open hole at the sheath lap joint assembly.Fluid was leaking from the open hole at the sheath lap joint assembly when the catheter was flushed.No kinks were observed along the length of the catheter.The telescope assembly was not able to properly pull back, advance, or retract, due to the windup found.During flushing, fluid was leaking at the sheath lap joint junction between the blue sheath and clear imaging window tubing.Impedance testing shows an electrical open at proximal wave form.During image characterization testing, no image appeared in the ilab system.Imaging core windup was found within the telescope section of the device.Windup was encountered in the double or single heat shrink area in the telescope area.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 of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2015.It was reported that lost image and catheter kinked occurred.The 90% stenosed target lesion was located in a moderately tortuous artery.During a percutaneous coronary intervention (pci), an opticross imaging catheter was used to visualize the lesion.However, upon usage of the device, image was lost and it as further noted that the imaging catheter shaft was kinked.The procedure was completed with same device.No patient complications were reported and the patient's status is good.However, device analysis revealed an open hole at the sheath lap joint assembly of the device.

• 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: 5012091
• MDR Text Key: 23395703
• Report Number: 2134265-2015-05442
• 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: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 17883913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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