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

Model Number 10706

Device Problem Break (1069)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported that catheter break occurred.An angiojet spiroflex was used for thrombectomy procedure.Upon preparation, the guide catheter was inserted and appeared to be cracked.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the spiroflex thrombectomy.The pump, effluent/supply line, shaft, tip, piston and spike line were visually inspected.Visual examination that the shaft is kinked and the hypotube is separated 40.7cm from the tip.Microscopic examination revealed no additional damages.

Event Description

It was reported that catheter break occurred.An angiojet spiroflex was used for thrombectomy procedure.Upon preparation, the guide catheter was inserted and appeared to be cracked.The procedure was completed with another of the same device.There were no patient complications reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15905072
• MDR Text Key: 305885400
• Report Number: 2124215-2022-49356
• Device Sequence Number: 1
• Product Code: MCX
• 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: 12/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0027027301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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