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

Model Number 109676-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Headache (1880); Pulmonary Edema (2020); Respiratory Failure (2484)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the patient was diagnosed with flash pulmonary embolism (pe) and went into respiratory arrest.An angiojet® solent¿ proxi catheter was used to treat a blockage of clot in the subclavian bifurcation.After approximately 90 seconds of thrombectomy treatment, the patient went into respiratory arrest.After the patient achieved homeostasis, the patient was diagnosed with flash pulmonary embolism.Chest x-ray results were insignificant according to radiologist who performed the fistulogram.The patient's pre-existing conditions and the culmination of intervention on the patient's fistulogram is believed to have been what sent the patient into respiratory arrest.The procedure was completed with balloon dilation with no further complications.Patient status post-procedure is reported as 'fine'.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported during the case the patient was complaining his head hurt.The physician would stop treatment for a little while and the symptoms would subside.It was also previously reported the patient was diagnosed with flash pulmonary embolism (pe).It was further clarified that the patient was not diagnosed with flash pulmonary embolism, but rather flash pulmonary edema (fluid around his lungs) by the chest x-ray done after the procedure was stopped.The patient was sent to icu on a bilevel positive airway pressure (bipap) machine.The patient underwent dialysis and was brought back to the cath lab the next day to complete the procedure.

• 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: 6364782
• MDR Text Key: 68529931
• Report Number: 2134265-2017-01351
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 109676-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR