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

Model Number	10706
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr.: the product was returned to boston scientific for analysis.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.No guidewire was stuck in the device.The catheter shaft showed multiple bends and kinks.The shaft of the device was separated approximately 35cm from the tip.Functional testing was not attempted due to the severe damage on the device.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 catheter difficulty removal and tip break occurred.An angiojet spiroflex was used in a thrombectomy procedure.During the introduction, it was noted that the catheter was stuck and the tip broke off when it was tried to remove.The device was then removed surgically.The procedure was cancelled.No patient complications were reported and patient was fully recovered and was okay.
Additional Manufacturer Narrative
Updated: h6 - impact codes.Device evaluated by mfr.: the product was returned to boston scientific for analysis.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.No guidewire was stuck in the device.The catheter shaft showed multiple bends and kinks.The shaft of the device was separated approximately 35cm from the tip.Functional testing was not attempted due to the severe damage on the device.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 catheter difficulty removal and tip break occurred.An angiojet spiroflex was used in a thrombectomy procedure.During the introduction, it was noted that the catheter was stuck and the tip broke off when it was tried to remove.The device was then removed surgically.The procedure was cancelled.No patient complications were reported and patient was fully recovered and was okay.It was further reported via medwatch (b)(4) that the detached tip was attempted to be removed with a snare but was unsuccessful.

• Brand Name: ANGIOJET SPIROFLEX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14474743
• Report Number: 2134265-2022-05798
• Device Sequence Number: 17476934
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0027921817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown