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

Model Number UNK956

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

Patient Problem Embolism (1829)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the patient experienced post procedural complications.The patient presented with claudication and foot pain.An angiojet solent proxi thrombectomy catheter was used along with angioplasty for treatment within the left iliac and the procedure was considered successful.Following the procedure, the patient did not wake up.The patient was intubated and kept under anesthesia until the following day.Once the patient was awake, the physician found that the patient's foot was not perfused as expected.An angiogram was performed and a distal clot was noted.It was unknown if the clot was present prior to the previous procedure.The physician used an angiojet and jetstream device to retrieve/debulk the clot burden with suboptimal results.The next day, the physician infused the patient with tpa, however, the results were again suboptimal.The day following tpa infusion, open thrombectomy was performed , however, again, they were only able to achieve suboptimal results.A few days later, the physician performed an above the knee amputation.Patient was reported to be recovering from above the knee amputation.

• 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: 6890436
• MDR Text Key: 87210442
• Report Number: 2134265-2017-09661
• 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
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• 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): Required Intervention
• Patient Age: 42 YR