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

Model Number B3847

Device Problem Knotted (1340)

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

Event Date 06/23/2017

Event Type  malfunction  

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 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.

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
• Type of Device: FAD
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita, ca 92688 ; AU 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 6775977
• MDR Text Key: 82696668
• Report Number: 2027111-2017-01936
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00607915112370
• UDI-Public: (01)00607915112370(17)190106(30)01(10)1262958
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 06/25/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1