MAUDE Adverse Event Report: APPLIED MEDICAL **B3857, SILH ZEBRA XTRAFLO DEV 6FX26CM; FAD

Model Number B3857

Device Problems Material Fragmentation (1261); Material Separation (1562)

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

Event Date 05/29/2015

Event Type  malfunction  

Event Description

Stent removal- "stent was in patient 9 months.During procedure to remove, stent came apart while the surgeon, dr.(b)(6) was trying to take it out." patient status: not known.

Manufacturer Narrative

The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.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.

Manufacturer Narrative

We have tried to obtain the incident device for evaluation with no success.It was verified on (b)(6) 2015 from our customer relation.The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot confirmed that the product passed all manufacturing and quality inspections.The root cause of the incident is unknown.Per the instructions for use (ifu), "if resistance is encountered during removal, fluoroscopically determine device position and cause of resistance." it is unclear if excessive force was used to remove the stent, which may cause the stent to break.Although the exact root cause of the incident could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.

Event Description

Additional information received from customer, october 08, 2015: an incomplete portion of the stent came out.Surgeon was able to remove the rest of the stent.The stent was broken into 2 different pieces.The stent was not able to be initially removed from the patient.The patient had to be taken into interventional radiology a week later where the removal was completed.No laser was used.Just grasping forceps.

• 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 ; 9497138233
• MDR Report Key: 4849296
• MDR Text Key: 5937783
• Report Number: 2027111-2015-00381
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2015,06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/16/2016
• Device Model Number: B3857
• Device Catalogue Number: 100964609
• Device Lot Number: 1207375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2015
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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