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 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for analysis.Device analysis revealed an open hole in the lapjoint area.Fluid was leaking from the lapjoint area when the catheter was flushed.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 was unable to be determined.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(4) 2016.It was reported that shaft kinked occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified distal circumflex artery (lcx).An opticross imaging catheter was selected for use.During preliminary intravascular ultrasound, the opticross imaging catheter was introduced; however, it was noticed that the shaft was kinked.The procedure was completed with another opticross imaging catheter.No patient complications were reported and the patient's status is good.However, device analysis revealed an open hole in the lap joint 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: 5570210
• MDR Text Key: 42439198
• Report Number: 2134265-2016-02601
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2016
• Device Model Number: H749518080
• Device Catalogue Number: 51808
• Device Lot Number: 18602823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2015
• 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