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

Model Number 10706

Device Problem Mechanical Jam (2983)

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

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: 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.The catheter shaft showed multiple bends and kinks.Microscopic analysis showed the guidewire was separated in the device approximately 19cm from the tip.There was also buckling on the guidewire inside the guidewire lumen located 2.5cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on the device analysis completed on (b)(6) 2021.It was reported that difficulty advancing the wire occurred.The target lesion was located in the superior mesenteric artery.An angiojet spiroflex was used in a thrombectomy procedure.During the procedure, the device successfully entered and withdrawn from the patient's body the first time it was advanced.However, upon preparing to enter the patient again, the non-bsc guidewire felt resistance advancing through the catheter.The guidewire was replaced several times but the issue was not resolved.The procedure was completed with another method.No patient complications were reported and patient's status was stable.However, returned device analysis revealed a separated guidewire entrapped on the catheter.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12095932
• MDR Text Key: 259365367
• Report Number: 2134265-2021-08263
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• 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: 0025765630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2021
• 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: 69 YR
• Patient Weight: 70