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

Model Number 10706

Device Problems Leak/Splash (1354); Suction Problem (2170); Defective Device (2588); Unexpected Shutdown (4019)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

It was reported that an error message occurred.The target lesion was located in the superior mesenteric artery.The spiroflex angiojet thrombectomy set was advanced for treatment.During the procedure, the system suddenly stopped and a liquid leaking from the pump, was noted.The issue was still unresolved after a reset.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that an error message occurred.The target lesion was located in the superior mesenteric artery.The spiroflex angiojet thrombectomy set was advanced for treatment.During procedure, the system suddenly stopped and a liquid leaking from the pump was noted.The issue was still unsolved even after reset.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that there was a loss of aspiration occurred during thrombectomy mode.

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 revealed multiple kinks along the shaft.Microscopic examination revealed no additional damages.Functional testing was performed by placing the device in the angiojet ultra console.The device was able to prime and run but there was a leak coming from a kinked spot on the shaft 22.5cm from that strain relief.Inspection of the device presented no other damage or irregularities.Product analysis of the device confirmed the presence of a leak.

Event Description

It was reported that an error message occurred.The target lesion was located in the superior mesenteric artery.The spiroflex angiojet thrombectomy set was advanced for treatment.During procedure, the system suddenly stopped and a liquid leaking from the pump was noted.The issue was still unsolved even after reset.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that there was a loss of aspiration occurred during thrombectomy mode.

• Brand Name: SPIROFLEX ANGIOJET THROMBECTOMY SET
• 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: 14365222
• MDR Text Key: 291465605
• Report Number: 2134265-2022-04852
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

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: 05/04/2022
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0025705584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 08/04/2022
• Supplement Dates FDA Received: 05/26/2022; 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2020
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG