MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G23406
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the patient got the universa firm ureteral stent on (b)(6) 2018.During a stent removal procedure, they were unable to remove the stent because of many encrustations on the stent.A second procedure had to be scheduled, where they used extracorporeal shock wave lithotripsy (eswl) to get the incrustations off the stent, to get it out.They finally succeeded with out any pain for the patient.No additional patient consequences were reported.
Additional Manufacturer Narrative
Investigation evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The customer returned one stent without the packaging or label for identification.The device was confirmed to be a 6 french 26cm stent.The device was returned in used condition.Light encrustation was observed on the outside of the tubing.During magnification, one side port was occluded with a calcified substance.Dark discoloration was observed on the outside of the stent.At the first side port in the distal coil, there were holes in the material with more encrustation inside the stent.The customer reported they had to use extracorporeal shock wave lithotripsy (eswl) to get the encrustations off the stent so it could be removed from the patient.No damage or encrustation was seen on the proximal coil.A review of the device history record found no non-conformances that could have contributed to this event.A search of complaint records revealed this is the only complaint associated with complaint device lot number 8430140.There have been no other complaints for stent encrustation on uhf stents since (b)(6) 2017.The fact that stents are in the urinary tract predisposes the device to urine¿s elements.Prevention is the best course to prevent encrustation.This includes diluting urine by increasing fluid intake and closely monitoring and treating urinary tract infections.Ureteral stent encrustation is a known inherent risk of the device.The instructions for use (ifu) booklet cautions: individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.A review of this device lot sales were reviewed.This customer purchased only 1 device from this lot; therefore, the additional complaints from this customer reported at the same time as this complaint are for different lot numbers.The customer indicated they "wondered" if a product change had contributed to these events.A review of changes for the stent component in manufacturing and inspection procedures was performed.There have been no changes during the time period around the date of manufacturing of this product.Additionally, there were no changes identified for the tubing raw material used to manufacture the stent.There is no evidence to suggest a manufacturing or material change contributed this event.Stent encrustation is documented in the ifu provided with the device.The patient anatomy and physiology is not known and could have contributed to this event.The investigation conclusion is encrustation is a known inherent risk of this device.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8009806
• Report Number: 1820334-2018-03246
• Device Sequence Number: 1706995
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)201208(10)8430140
• Combination Product (Y/N): N
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2020
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 8430140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other