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

Model Number H749305900180

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2017-03998; 2134265-2017-03999.It was reported that automatic pullback failure occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified right femoral artery.An opticross¿ 18 imaging catheter was used in conjunction with an ilab ultrasound imaging system and pullback sled to view the target lesion.During the procedure, the imaging catheter was able to engage but it was unable to perform auto pullback.When it was checked, it was found out that the shaft part was slightly kinked.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned.Device analysis revealed that a kink was observed in the telescope assembly from femoral marker to the proximal end.The telescope assembly was not able to properly pull back manually and automatically, due to the kink in the telescope, the sled was not returned with the catheter the test was performed with a control sled in the complaint lab.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).

Event Description

Same case as mdr id: 2134265-2017-03998; 2134265-2017-03999.It was reported that automatic pullback failure occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified right femoral artery.An opticross¿ 18 imaging catheter was used in conjunction with an ilab ultrasound imaging system and pullback sled to view the target lesion.During the procedure, the imaging catheter was able to engage but it was unable to perform auto pullback.When it was checked, it was found out that the shaft part was slightly kinked.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 6500764
• MDR Text Key: 73095370
• Report Number: 2134265-2017-03682
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2017
• Device Model Number: H749305900180
• Device Catalogue Number: 30590-018
• Device Lot Number: 19976083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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
• Treatment: GUIDE WIRE: JUPITER FC; INTRODUCER SHEATH: TERUMO DESTINATION