MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SPIROFLEX® ANGIOJET® THROMBECTOMY SET; CATHETER, EMBOLECTOMY

Model Number 106553-001

Device Problems Device Displays Incorrect Message (2591); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of a spiroflex thrombectomy device with no other devices.The pump, shaft, and tip were microscopically examined and there were no damage or irregularities noted.During functional testing it was observed that there was a leak at the male connector with female luer.Fluid leaking from the connector is in indication that the outlet adapter seal failed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).

Event Description

Same case as: 2134265-2017-04997, 2134265-2017-04993.It was reported that an error message displayed during aspiration of the circumflex and obtuse marginal arteries.An angiojet® ultra system console and spiroflex® angiojet® thrombectomy set were selected for a thrombectomy procedure in the circumflex and obtuse marginal arteries.The device prepped normally.A green light displayed and the catheter was places over the coronary wire in a normal fashion.Aspiration was initiated for 2-5 seconds and then an error message displayed that there was a kinked catheter and to look for a kink.There was no kink visible on the catheter.The catheter was removed from the patient and re-prepared.A green light displayed and the device was placed back into the body where it performed aspiration for 2-5 seconds and gave the kink message again.A second spiroflex® angiojet® thrombectomy set was pulled.The catheter would not prime properly.There was an error about priming during preparation, however, they got the device to prime.The device was placed inside the patient and the kink error displayed after 2 seconds.A non-bsc manual aspiration catheter was used to complete the procedure with good results.The patient received stenting to left anterior descending artery.There were no patient complications and the patient was stable and fine.After this event, the catheter was prepped again outside the body.It prepped in a normal fashion with a green light.Thrombectomy was performed in a cup on the table for 30 seconds and then a kink catheter message was observed.

• Brand Name: SPIROFLEX® ANGIOJET® THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6602837
• MDR Text Key: 76407756
• Report Number: 2134265-2017-05012
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• 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
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 106553-001
• Device Lot Number: 19523049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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: 70 YR