MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939293061530

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported the device became contaminated.A 6 x 150 x 130 innova¿ was selected for a procedure in the superficial femoral artery (sfa).During unpacking, the tech pulled the stent out of the hoop and it sprung up and hit her glasses.This contaminated the tip of the catheter.Another innova¿ was opened and deployed to complete the procedure.The patient did well and there were no patient complications.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 6956730
• MDR Text Key: 90414669
• Report Number: 2134265-2017-09972
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• 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: 09/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2020
• Device Model Number: H74939293061530
• Device Catalogue Number: 39293-06153
• Device Lot Number: 0020800465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• 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