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

Model Number 109681-001

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported a crack in the catheter shaft occurred.An angiojet® solent¿ omni was selected for a thrombectomy procedure in the leg.The device was primed then inserted into the sheath inside the patient.Approximately half way through the thrombectomy procedure, a crack was noted on the gold distal section of the catheter shaft, about 3cm before shaft turns into the purple section.A holder was placed over the crack to keep it from spraying out everywhere and this device was used to complete the procedure.No error messages displayed.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the catheter portion of the solent omni thrombectomy system.The stopcock, effluent line, supply line and pump were not returned for analysis.The shaft and tip were microscopically, tactile and visually inspected.Inspection revealed that the customer cut ¿off the effluent tubing/supply line and removed the stopcock.There were numerous kinks throughout the shaft.There was a hole in the pebax over the stainless steel braid of the shaft 31cm from the tip.The stainless steel shaft was pulled apart and kinked in the location of the hole.Functional testing was not able to be performed, as the device was cut apart and portion of the device was not returned for analysis.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.Bsc id # (b)(4)/ tw# (b)(4).

Event Description

It was reported a crack in the catheter shaft occurred.An angiojet® solent¿ omni was selected for a thrombectomy procedure in the leg.The device was primed then inserted into the sheath inside the patient.Approximately half way through the thrombectomy procedure, a crack was noted on the gold distal section of the catheter shaft, about 3cm before shaft turns into the purple section.A holder was placed over the crack to keep it from spraying out everywhere and this device was used to complete the procedure.No error messages displayed.No patient complications were reported and the patient's status is fine.

• 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: 6777564
• MDR Text Key: 82171997
• Report Number: 2134265-2017-08018
• 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,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 109681-001
• Device Catalogue Number: 109681
• Device Lot Number: 20014504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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