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

Model Number UNK872

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Event date: in the last 3 years.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

It was reported that the patient experienced pancreatitis.Following a thrombectomy procedure within the past 3 years, with an unknown angiojet catheter, a patient experienced pancreatitis.Additional information has been requested and is currently not available.

• Brand Name: ANGIOJET®
• 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: 7367054
• MDR Text Key: 103355861
• Report Number: 2134265-2018-02195
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2018

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: UNK872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/23/2018
• 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