MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿ 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H7493932800180

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that missing radiopaque markers occurred the target lesion was located at the tibial artery.An opticross¿ 18imaging catheter was selected for use.During the peripheral intervention/angioplasty of tibial vessel.The catheter was prepared as directed and everything was fine.However, when the opticross¿ 18 imaging catheter was inserted into the patient the physician was trying to place it into the vessel but he could not see the radiopaque markers at all.They scanned it in the entire vessel, but they could not find the radiopaque markers so they decided to flush the catheter and physician pulled back the telescoping segment and tried to flush, it wouldn't flush and then he couldn't put the telescoping segment back in to the catheter.The procedure was completed with a different device.No patient complications were reported and the patient¿s status is fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed that the a damage was observed on the guidewire exit port assembly.A kink was observed in the imaging window assembly in the distal end.A kink was observed in the sheath assembly from femoral marker to the distal end.No other visual damages were encountered upon visual inspection, moreover the markers and the ro marker were in the correct place and present in the catheter.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.The device was sent for x-ray analysis.Based on the x-ray images, the marker was visible in x-ray analysis.The manufacturing batch review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that missing radiopaque markers occurred.The target lesion was located at the tibial artery.An opticross 18imaging catheter was selected for use.During the peripheral intervention/angioplasty of tibial vessel.The catheter was prepared as directed and everything was fine.However, when the opticross 18 imaging catheter was inserted into the patient the physician was trying to place it into the vessel but he could not see the radiopaque markers at all.They scanned it in the entire vessel, but they could not find the radiopaque markers so they decided to flush the catheter and physician pulled back the telescoping segment and tried to flush, it wouldn't flush and then he couldn't put the telescoping segment back in to the catheter.The procedure was completed with a different device.No patient complications were reported and the patient¿s status is fine.

• Brand Name: OPTICROSS¿ 18
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7399244
• MDR Text Key: 104611226
• Report Number: 2134265-2018-03033
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: TBD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2020
• Device Model Number: H7493932800180
• Device Lot Number: 21695580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR