MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939031601610

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

Patient Problems Intimal Dissection (1333); Embolism (1829)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

The complaint device was not returned for analysis.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(4) clinical study.It was reported that vessel dissection and embolism occurred.In (b)(6) 2017, the index procedure was performed.The 100% stenosed, 95mm long with a reference vessel diameter of 6.5mm, and classified as a tasc ii b target lesion was located in the left superficial femoral artery (sfa).The lesion was treated with pre-dilatation using 5 mm x 100 mm balloon and standard percutaneous transluminal angioplasty with a 6.0mmx150mmx150cm (4f) sterling¿ balloon catheter.Following this intervention, a grade b dissection was noted which was treated with balloon dilatation.Post dilatation was also performed.Furthermore, embolism was noted in the left peroneal artery and posterior artery.This complication was treated with thrombus aspiration and balloon dilatation.On the same day, the event was considered to be resolved and the patient was discharged with cilostazol and clopidogrel.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 6970886
• MDR Text Key: 90027083
• Report Number: 2134265-2017-10337
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H74939031601610
• Device Catalogue Number: 39031-60161
• Device Lot Number: 19232883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR