MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ OMNI; CATHETER, EMBOLECTOMY

Model Number 109681-001

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: a visual examination identified a kink 35cm distal of the strain relief.Functional testing was performed and the device ran within the normal range, without any leaks from the hub; however, the shaft leaked at the kink.The shaft was microscopically examined and it was noticed that there was a hole in the shaft at the same location as the kink (35cm distal of the strain relief).Because there was no evidence of any product quality deficiencies, it was considered likely that the kink and hole in the shaft were attributable to the handling of the device.The overall investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Reportable based on the product analysis completed on april 26, 2018.It was reported, during preparation for use of an angiojet solent omni thrombectomy catheter, the hub was cracked and leaked during priming.The device was never introduced to the patient.No patient complaints were reported.However, the returned product analysis revealed a hole in the shaft.

• Brand Name: ANGIOJET® SOLENT¿ OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7473170
• MDR Text Key: 106915962
• Report Number: 2134265-2018-04293
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2019
• Device Model Number: 109681-001
• Device Catalogue Number: 109681
• Device Lot Number: 21557709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2017
• 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