MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number UNK873

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

Patient Problems Death (1802); Injury (2348)

Event Type  Death  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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

Same case as mdr id: 2134265-2017-02560.It was reported that there was a poor patient outcome.An angiojet® ultra system console and angiojet® solent¿ omni catheter were selected for a thrombectomy procedure.A 100ml bag of tissue plasminogen activator (tpa) was used.The catheter was primed and placed into the patient.Power pulse was completed for 55 seconds.Then, the rest of the tpa bag was inadvertently used for aspiration of the lesion until the machine alarmed to indicate the bag was empty.There was a poor patient outcome.

Manufacturer Narrative

Updated: age at time of event, outcomes attrib.To ae, describe event or problem, other relevant history, patient codes, type of reportable event age at time of event: over 80 years.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-02560.It was further reported that the patient had undergone an endovascular aneurysm (aortic) repair (evar) one day prior and then returned to the operating room for an emergency laparotomy to locate and ligate a bleed.The patient was then intubated and in the intensive care unit (icu).The following day the patient underwent a thrombectomy and embolectomy of common iliac artery (cia) and limb, with open laparotomy wound with vac dressing insitu.The saline bag was prepped with 15 mg of tissue plasminogen activator (tpa) in 100 ml normal saline.Once the machine alarmed to indicate the bag was empty, the saline clamp was released for the remainder of the thrombectomy mode.Consequently, the patient died as a result of bleeding complications.

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6427049
• MDR Text Key: 70624183
• Report Number: 2134265-2017-02508
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other