MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® SOLENT¿ PROXI; CATHETER, CONTINUOUS FLUSH

Model Number 109676-001

Device Problems Device Stops Intermittently (1599); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2016

Event Type  malfunction  

Manufacturer Narrative

Patient age at time of event: over 18.(b)(4).

Event Description

It was reported catheter stopped working intermittently during aspiration.During the use of a angiojet(tm) solent(tm) proxi catheter in a thrombectomy procedure, the catheter was only working intermittently.The catheter was removed from the patient and another of the same was used to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination, there was no damage or irregularity in the catheter the connector.The thrombectomy system was inserted in to the ultra-console for functional testing.The catheter would not get into priming mode and received a ¿check saline supply ¿error.Functional testing showed a leak at the male connector with female luer.Fluid leaking from the connector is in indication that the outlet adapter seal failed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported catheter stopped working intermittently during aspiration.During the use of a angiojet® solent¿ proxi catheter in a thrombectomy procedure, the catheter was only working intermittently.The catheter was removed from the patient and another of the same was used to complete the procedure.No patient complications were reported.

• Brand Name: ANGIOJET® SOLENT¿ PROXI
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 5746339
• MDR Text Key: 48096989
• Report Number: 2134265-2016-05493
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101406
• 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,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 109676-001
• Device Lot Number: 18844525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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