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

Model Number 109681-001

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - the returned product consisted of and angiojet solent omni thrombectomy system.Visual and tactile examinations showed that there was a break in the hypo tube approximately 56cm from the tip of the catheter.The thrombectomy system was inserted in to the ultra console for functional testing.The solent omni would not prime.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).

Event Description

Reportable based on analyis completed on 12oct2015.It was reported that the angiojet® solent¿ omni "did not work".However; returned device analysis revealed a shaft break.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5213386
• MDR Text Key: 30853762
• Report Number: 2134265-2015-07464
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 109681-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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