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

Model Number H7493932800180

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Same case as: 2134265-2017-06032.It was reported that catheter entanglement occurred.Vascular access was obtained via the right brachial artery.The target lesion was located in the right iliac artery.An opticross¿ 18 imaging catheter was selected for use.During the procedure, a 5f 11cm super sheath was placed in the right brachial artery then a 5f 100cm imager ii diagnostic catheter was inserted to reach right iliac artery which had a stent placed previously.A v-18¿ control wire was then placed in order to use the opticross¿ 18 imaging catheter to view the lesion.However, the opticross¿ 18 imaging catheter was first recognized as an ultra ice plus ¿ imaging catheter.A few disconnection and reconnection were attempted, but the issue was not resolved.The ilab system was shut down and restarted and the opticross¿ 18 imaging catheter was finally recognized correctly.While the opticross¿ 18 was in use, the device failed to cross the iliac artery where the previously implanted stent was placed.As the opticross¿ 18 imaging catheter did not have enough rail support, this resulted to the opticross¿ 18 and the v-18¿ control wire to loop within the artery.After a couple of attempts to resolve the issue, the screen went blank and the physician decided to abandon the use of opticross.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Device analysis revealed a damage on the guidewire exit port assembly.No damages or failures were observed on the ccp board assembly.No other visual damages were encountered upon visual inspection.The telescope assembly was able to properly pull back, advance, and retract.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.The catheter was properly recognized by the imaging system when plugged into the motordrive unit (mdu) and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.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

It was reported that catheter entanglement occurred.Vascular access was obtained via the right brachial artery.The target lesion was located in the right iliac artery.An opticross 18 imaging catheter was selected for use.During the procedure, a 5f 11cm super sheath was placed in the right brachial artery then a 5f 100cm imager ii diagnostic catheter was inserted to reach right iliac artery which had a stent placed previously.A v-18 control wire was then placed in order to use the opticross 18 imaging catheter to view the lesion.However, the opticross 18 imaging catheter was first recognized as an ultra ice plus imaging catheter.A few disconnection and reconnection were attempted, but the issue was not resolved.The ilab system was shut down and restarted and the opticross 18 imaging catheter was finally recognized correctly.While the opticross 18 was in use, the device failed to cross the iliac artery where the previously implanted stent was placed.As the opticross 18 imaging catheter did not have enough rail support, this resulted to the opticross 18 and the v-18 control wire to loop within the artery.After a couple of attempts to resolve the issue, the screen went blank and the physician decided to abandon the use of opticross.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: 6607725
• MDR Text Key: 76519720
• Report Number: 2134265-2017-05651
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: H7493932800180
• Device Lot Number: 20379343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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