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 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter entanglement occurred.The target lesion was located in a severely tortuous right and left common iliac artery.An opticross¿ imaging catheter was selected for use.During the procedure, the physician performed diagnostic runs in both the right and the left common iliac artery and then they stent it and went to take approach the then post-stent.The opticross¿ imaging catheter would not advance past the sheath so they took the opticross¿ imaging catheter out and looking at the tip of the catheter if the v-18 guidewire had exited appropriately.Upon checking, there is a big kink where the v-18 guidewire exits the monorail port.So they got the second opticross¿ imaging catheter that worked just fine to do the first run in the left leg.Furthermore, they found out that they needed to put a stent in the external iliac artery, so they stented and then took the ivus (intravenous ultrasound) catheter back on the v-18 guidewire to do the ivus.However, the same situation happened.As soon as the tip of the ivus catheter exited, it was bent over on itself and got stuck and would not advance.So the physician pulled the v-18 guidewire and everything out.The ivus catheter was all twisted and bent on the v-18 guidewire.They did an angiogram to complete the procedure.No patient complications reported and the patient's status is fine.

Manufacturer Narrative

Updated: describe event or problem.Bsc id# (b)(4).Tw# (b)(4).

Event Description

Same case as: 2134265-2017-08373.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a damage was observed on the distal tip and the guidewire exit port assembly.A kink was observed in the telescope assembly from femoral marker to the proximal end.A kink was observed in the sheath assembly from femoral marker to the proximal end.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.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

It was reported that catheter entanglement occurred.The target lesion was located in a severely tortuous right and left common iliac artery.An opticross¿ imaging catheter was selected for use.During the procedure, the physician performed diagnostic runs in both the right and the left common iliac artery and then they stent it and went to take approach the then post-stent.The opticross¿ imaging catheter would not advance past the sheath so they took the opticross¿ imaging catheter out and looking at the tip of the catheter if the v-18 guidewire had exited appropriately.Upon checking there is a big kink where the v-18 guidewire exits the monorail port.So they got the second opticross¿ imaging catheter that worked just fine to do the first run in the left leg.Furthermore, they found out that they needed to put a stent in the external iliac artery, so they stented and then took the ivus (intravenous ultrasound) catheter back on the v-18 guidewire to do the ivus.However, the same situation happened.As soon as the tip of the ivus catheter exited, it was bent over on itself and got stuck and would not advance.So the physician pulled the v-18 guidewire and everything out.The ivus catheter was all twisted and bent on the v-18 guidewire.They did an angiogram to complete the procedure.No patient complications 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: 6771201
• MDR Text Key: 81962400
• Report Number: 2134265-2017-07869
• 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,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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: 20379344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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
• Patient Age: 83 YR