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

Model Number	10706
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter stuck on wire occurred.The target lesion was located below the knee.An angiojet spiroflex catheter was selected for thrombectomy procedure.However, during insertion, it was noted that the monorail segment portion of the catheter was stuck in an unknown guidewire.The devices were removed together as one.A new guidewire was inserted and another of the same angiojet spiroflex was used and procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that catheter stuck on wire occurred.The target lesion was located below the knee.An angiojet spiroflex catheter was selected for thrombectomy procedure.However, during insertion, it was noted that the monorail segment portion of the catheter was stuck in an unknown guidewire.The devices were removed together as one.A new guidewire was inserted and another of the same angiojet spiroflex was used and procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a spiroflex thrombectomy system with an unknown guidewire inside the wire lumen.The guidewire was kinked and protruding from the exit notch and the tip of the spiroflex catheter.The unknown guidewire was measured and confirmed to be a 0.14" guidewire.The pump, effluent/supply line, shaft and tip were microscopically and visually inspected.Fluid was present inside the device and attached waste bag when received, indicating that the device was primed.Visual inspection of the device revealed that the exit notch was found to have been tore and the outer shaft was damaged with material pulled at the windows from the tip proximally for 10cm.Microscopic examination revealed that the inner wire lumen was buckled 10.5cm distal of the exit and 6mm - 2.6cm proximal of the tip with the tip damaged.An attempt to remove the guidewire from the catheter shaft was unsuccessful due to the buckled wire lumen.The damage to the shaft and wire lumen is consistent to damage caused by resistance with the guidewire during advancement.As the guidewire also was also kinked, this is another indication that there was resistance between the catheter and wire.

• Brand Name: ANGIOJET SPIROFLEX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9473485
• Report Number: 2134265-2019-15779
• Device Sequence Number: 16856914
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 08/09/2021
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0024581966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1