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

Model Number 109676-003

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Returned product consisted of a solent proxi thrombectomy system with no other devices.The pump, supply line, shaft and tip were microscopically, tactile and visually inspected.Inspection revealed damage (kink and a hole) to the outer shaft, located 44cm from the tip of the device.Functional testing was performed by placing the device in the console.Functional testing consisted of running the complaint device through the full priming cycle and 180 seconds in thrombectomy mode.The device ran within normal range without any issue/alarms.Inspection of the remainder of the device found no damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Reportable based on device analysis completed on 05jul2017.It was reported that the catheter failed to prime.An angiojet® solent¿ proxi and a angiojet® solent¿ omni were selected for a thrombectomy procedure to treat a pulmonary embolus.During priming, outside the patient, it was noted that pooling of the heparin/saline accumulated around the pump of the console and the catheter failed to prime.The solent omni was then selected and the same issue occurred.The procedure was completed using another technique.There were no patient complications and the patient's condition was stable.However, device analysis revealed a hole in the shaft.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6728682
• MDR Text Key: 80572412
• Report Number: 2134265-2017-07284
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 109676-003
• Device Lot Number: 20454122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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