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

Model Number UNK695

Device Problem Entrapment of Device (1212)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: mdr id: 2134265-2018-06299, mdr id: 2134265-2018-06301.It was reported that the wire felt stuck when removing it from this device.An innova¿ stent was selected for use during a patient procedure.When removing the unspecified wire from this device during the procedure, the wire became bent and then felt stuck when removing it from this device.This issue has been experienced by the physician a couple of times.No patient complications were reported.

• Brand Name: INNOVA SELF-EXPANDING STENT SYSTEM
• 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: 7693718
• MDR Text Key: 114158517
• Report Number: 2134265-2018-06300
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• 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