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

Model Number H749518120

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

Reportable based on the device analysis completed on (b)(4) 2014.It was reported that a catheter kink was noted.During percutaneous coronary intervention (pci) procedure, an opticross¿ imaging catheter was used in order to visualize the unknown target lesion.However, upon insertion of the device, the physician noticed a kink in the catheter.The procedure was then completed with another of the same device.No patient complications were reported and the patient's status is stable.However, after completion of the device analysis, it was revealed that the sheath assembly was found to be detached from the blue tubing at the lap joint.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.After device analysis, it was noted that kinks were observed in the sheath assembly at 33.0 cm from femoral marker to the distal end and on the detached clear tubing at 18.0 cm from the distal tip.The sheath assembly was found to have the clear tubing detached from the blue tubing at the lap joint.This fully exposes the imaging core.No image appeared in the system due to electrical open at distal.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4111383
• MDR Text Key: 4919473
• Report Number: 2134265-2014-05645
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K123621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2014

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: 04/21/2015
• Device Model Number: H749518120
• Device Catalogue Number: 51812
• Device Lot Number: 16910160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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