MAUDE Adverse Event Report: APPLIED MEDICAL ZZ**B3837, TETH SILHOU STENT 4FX26CM, 1/; FAD

Model Number B3837

Device Problem Break (1069)

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

Event Date 12/03/2014

Event Type  malfunction  

Event Description

Patient status - "na - i have contacted the dr.2 times to get patient status and he has not responded to my email to confirm.He seemed to think that the patient was fine.Follow up was last week.Have since sent him 2 emails" updated 12/31/14 per rep jj shearon the patient is recovering.

Manufacturer Narrative

Additional information - updated 12/31/14 per rep (b)(6) the patient is recovering.Investigation summary: the incident product was not returned for evaluation and a lot number was not provided.In the absence of the subject device, it is difficult to determine the root cause of the incident.Because the unit was not returned and the lot number is unknown, further details are needed to make a more thorough investigation.Testing was reviewed to ensure that all protocols were met.All stents undergo 100% inspection for kinks, cracks, and overall quality during the manufacturing and assembly process.This document represents our final report.

Event Description

Stent removal - "exact email from dr.(b)(6) 'i use the 4.6 stents very routinely as numbers will show at (b)(6).However, i had an unfortunate episode where the stent and the wire broke when i was trying to remove via a percutaneous (via kidney approach).' " intervention - "stent had to be removed in or." patient status - "na".

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

• Type of Device: FAD
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 949713-823
• MDR Report Key: 4376065
• MDR Text Key: 16892407
• Report Number: 2027111-2014-00394
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2014,01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: B3837
• Device Catalogue Number: 100884610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2014
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2015
• 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
• Patient Outcome(s): Other; Required Intervention