MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B3847, SIL MUL-LGTH XTRAFLO 6FX22-30CM; FAD

Model Number	B3847
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: removal of stent.Incident description: stent inserted on (b)(6) 2017, removed (b)(6) 2017.Proximal end of stent "knotted" in renal pelvis.See ureter breached diathermy to extract stent.Further information from urologist.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed the complainant's experience of knotting at the proximal end of the stent body.The wire was exposed in the location of the knot.The root cause of the reported event could not be determined.The formation of knots is rare and publications from medical literature have found that excessive length and presence of additional coils may contribute to knot formation in multi-length ureteral stents.As such, the instructions for use (ifu) includes the following warning, "formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal." 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.

• Brand Name: B3847, SIL MUL-LGTH XTRAFLO 6FX22-30CM
• Common Device Name: FAD
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita, ca 92688 ; AU 92688
• MDR Report Key: 6775977
• Report Number: 2027111-2017-01936
• Device Sequence Number: 964680
• Product Code: FAD
• UDI-Device Identifier: 00607915112370
• UDI-Public: (01)00607915112370(17)190106(30)01(10)1262958
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K040760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/06/2019
• Device Model Number: B3847
• Device Catalogue Number: 100989701
• Device Lot Number: 1262958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2017
• Supplement Date Received by Manufacturer: 06/25/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1