MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY

Model Number	10707
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft damage occurred.An angiojet spiroflex vg was selected for use in a thrombectomy procedure.The target lesion was located in the saphenous vein graft.During insertion, it was noted that resistance was felt while the catheter was advancing onto the guidewire.The metal shaft was found to be unraveling, but still intact.The procedure was completed successfully, with another angiojet spiroflex vg.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet spiroflex catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.There was one area located 84cm from the tip that was unraveling/stretching and leaked fluid.Functional testing was completed per the device preparation.The pump was inserted into the ultra-drive unit console.The pump and catheter were primed and were run for a period of 120 seconds in the thrombectomy mode.The device's pressure was within the normal range of 10.568 kpsi.No failures or error codes were noticed during the testing.A leak was noticed in the stretched area located at 84cm.Inspection of the remainder of the device apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that shaft damage occurred.An angiojet spiroflex vg was selected for use in a thrombectomy procedure.The target lesion was located in the saphenous vein graft.During insertion, it was noted that resistance was felt while the catheter was advancing onto the guidewire.The metal shaft was found to be unraveling, but still intact.The procedure was completed successfully, with another angiojet spiroflex vg.There were no patient complications reported.

• Brand Name: ANGIOJET SPIROFLEX VG
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11839475
• Report Number: 2134265-2021-06430
• Device Sequence Number: 4635241
• Product Code: MCX
• UDI-Device Identifier: 08714729889441
• UDI-Public: 08714729889441
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K080806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: 10707
• Device Catalogue Number: 10707
• Device Lot Number: 0024343476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1