MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H749518080

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Device analysis revealed an open hole in the lapjoint area.A kink was observed in the sheath assembly from femoral marker to the distal end.Fluid was leaking from the lapjoint area when the catheter was flushed.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).

Event Description

Reportable based on device analysis completed on 14mar2016.It was reported that catheter kink occurred.The target lesion was located in the severely tortuous and mildly calcified left main coronary artery.An opticross¿ imaging catheter was used to view the target lesion.During percutaneous coronary intervention (pci), the opticross¿ imaging catheter was advanced; however, it was noted that the exit port part of the device got kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition is good.However, device analysis revealed an open hole in the lapjoint area.

• Brand Name: OPTICROSS¿
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5548537
• MDR Text Key: 41939980
• Report Number: 2134265-2016-02513
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2016

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: 10/14/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 18493619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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