MAUDE Adverse Event Report: APPLIED MEDICAL B3857, SILH XTRAFLO DEVICE 6FX26CM; FAD

Model Number B3857

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Stent removal - "stent was put in (b)(6) 2015.When dr (b)(6) went to remove the stent it was embedded in the patients ureter the stent came out in pieces with one of the coiled pigtails was also in pieces.Patient status - "patient is okay".

Manufacturer Narrative

Customer's pathology department was keeping product so it was not returning.The event unit was not returned for evaluation; only photographs of the event unit taken by the user facility were received.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.During the manufacturing process, the integrity of the stents is checked at multiple stages prior to packaging.As stated in the instructions for use (ifu), "potential complications associated with the use of ureteral stents include but are not limited to: migration or dislodgment, encrustation, infection, breakage or fragmentation, kinking, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, reflux, stone formation, obstruction, erosion, and perforation of kidney, renal pelvis, ureter or bladder." although the exact root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Additional information received via email from applied team member on february 9, 2016: spoke with the nurse again.She said the date it was removed was (b)(6) 2015.A laser was not used.The stent broke during removal.A picture was sent with the cer of the stent, which shows where the stent was broken, mainly the coil.The stent was sent to pathology.She didn't say anything about patient anatomy being a factor.

• Brand Name: B3857, SILH XTRAFLO DEVICE 6FX26CM
• Type of Device: FAD
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5227242
• MDR Text Key: 31520978
• Report Number: 2027111-2015-00790
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/21/2016
• Device Model Number: B3857
• Device Catalogue Number: 100964609
• Device Lot Number: 1210335
• Other Device ID Number: 00607915112479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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