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

Model Number H74939181062030

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.With the limited information available and the unavailability of the device for analysis, no further analysis or investigation was possible.A review of all information available for consideration at the time of this investigation was insufficient to confirm the reported event and determine the exact cause.It is notable that there is no evidence of any specification non-conformances related to the complaint device.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the product sterility was compromised.No additional information is available.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5880741
• MDR Text Key: 52617801
• Report Number: 2134265-2016-07720
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: H74939181062030
• Device Catalogue Number: 39181-06203
• Device Lot Number: 18972076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1