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

Model Number H74939180061570

Device Problems Entrapment of Device (1212); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

It was reported that during a stenting treatment procedure, the innova 6x150x75 stent jumped and got stuck in the sheath.No patient complication have been reported.Futher information has been requested but has not been obtained.

Manufacturer Narrative

Device evaluated by manufacturer: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3942294
• MDR Text Key: 4641121
• Report Number: 2134265-2014-04332
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2014

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: 05/14/2015
• Device Model Number: H74939180061570
• Device Catalogue Number: 39180-06157
• Device Lot Number: 15244503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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