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

Model Number	10706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the coronary artery.An angiojet spiroflex catheter was selected for a thrombectomy procedure.However, it was noted that the catheter would not prime.Another angiojet spiroflex catheter was advanced and completed the procedure; however, during withdrawal, the catheter was broken.The device was completely removed from the patient's body.No patient complications were reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a spiroflex thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.Blood was inside the device and the waste bag was cut-off, when received.The waste bag was not returned for analysis.Inspection of the device revealed that the shaft was kinked 47cm distal of the strain relief with a hole in the shaft at the same location.
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the coronary artery.An angiojet spiroflex catheter was selected for a thrombectomy procedure.However, it was noted that the catheter would not prime.Another angiojet spiroflex catheter was advanced and completed the procedure; however, during withdrawal, the catheter was broken.The device was completely removed from the patient's body.No patient complications were reported and patient was fine.

• 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: 9695608
• Report Number: 2134265-2020-01136
• Device Sequence Number: 2824459
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/10/2020

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: 10/27/2020
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0023119943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1