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

Model Number 10706

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 292476785
• Report Number: 2134265-2022-05798
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 05/27/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention