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

Model Number	10706
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.Returned product consisted of a spiroflex thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were microscopically and visually inspected.There was fluid in the boot and the device, when received.The fluid indicates that the device was prepped and primed, not just taken out of the package and not used as reported.Inspection of the device revealed numerous kinks throughout the shaft.Closer examination revealed that the hypotube was separated 40.5cm proximal of the tip.The separated ends of the hypotube were ovaled, indicating that the hypotube was kinked prior to separation.Product analysis confirmed the reported event, as the shaft had numerous kinks; however, there was fluid in the device indicating that the device was prepped and primed not just taken out of the package and not used, as reported.
Event or Problem Description
Reportable based on device analysis completed on 10-june-2020.It was reported that the catheter got kinked.An angiojet spiroflex thrombectomy catheter was used for treatment.During preparation, a kink was noted when the device was unpacked.The procedure was completed with a different device.No patient complications reported.However, device analysis revealed that the hypotube separated 40.5cm proximal of the tip.

• 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: 10164277
• Report Number: 2134265-2020-08066
• Device Sequence Number: 2400860
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: 07/07/2021
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0024465422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1