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 Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that entrapped on guidewire occurred.An angiojet spiroflex was used to treat the lesion.The catheter was successfully used for two passes, on the third pass the wire and catheter became stuck.Both the catheter and wire were removed.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that entrapped on guidewire occurred.An angiojet spiroflex was used to treat the lesion.The catheter was successfully used for two passes, on the third pass the wire and catheter became stuck.Both the catheter and wire were removed.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
D4 - lot number: lot number is either: 24544997, 24478015, and 24193451.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.014" guidewire.The pump, effluent/supply line, shaft and tip were microscopically and visually inspected.Blood was present inside the device and the waste bag was cut-off, when received.The waste bag was not returned for analysis.Visual inspection of the device revealed that the catheter had numerous kinks.The exit notch was found to have been torn and the outer shaft was buckled 8cm - 9cm distal of the exit notch and stretched 13c, - 14cm distal of the exit notch.Microscopic examination revealed that the inner wire lumen was buckled 18cm - 25.5cm distal of the exit notch (ended at the shaft/tip transition).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 or use of the catheter during the procedure.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: 9412172
• Report Number: 2134265-2019-14935
• Device Sequence Number: 14508292
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 06/08/2021
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0024450568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR