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

Model Number	G49976
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: practice manager 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
As reported, during a ureteroscopy with stone lithotripsy and stent removal procedure, when they pulled on the universa soft ureteral stent, there was no tension on the stent it pulled right out ,but the stent severed in half.A broken piece of the stent remained in the patient's kidney, as the physician was unable to remove it.There were two stents in the patient and one of the stents was removed successfully without any issues.Additional information was received 11may2021: the broken piece of the stent was removed via a flexible cystoscope, and the ureteroscopy with stone lithotripsy was completed.No additional patient consequences were reported.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a ureteroscopy with stone lithotripsy and stent removal procedure, when they pulled on the universa soft ureteral stent, there was no tension on the stent it pulled right out ,but the stent severed in half.A broken piece of the stent remained in the patient's kidney, as the physician was unable to remove it.There were two stents in the patient and one of the stents was removed successfully without any issues.Additional information was received 11may2021: the broken piece of the stent was removed via a flexible cystoscope, and the ureteroscopy with stone lithotripsy was completed.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.The complainant returned two used universa soft ureteral stent sets, ush-630-r, to cook for investigation.Visual examination of the device found that one of the products was returned broken into two pieces and the other was intact.The intact device measured 30 cm.The tips of the devices are round and smooth.The damaged device sections measured 18.5 cm and 11.5 cm.The point of separation was at a side port and the separation points appear to be mating fractures.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: -the universa soft stents must not remain indwelling more than six months.If the patient¿s status permits, the stent may be replaced with a new stent.- these stents are not intended as permanent indwelling devices.- do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.- improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.-individual variations of interaction between stents and the urinary system are unpredictable.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A clinical evaluation of the complaint concluded product handling, medical procedure, inadvertent user error, or device failure could not be ruled out as possible causes of this event based on the available information.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database 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.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11885533
• Report Number: 1820334-2021-01399
• Device Sequence Number: 3223322
• Product Code: FAD
• UDI-Device Identifier: 10827002499765
• UDI-Public: (01)10827002499765(17)220530(10)9772445
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: G49976
• Device Catalogue Number: USH-630-R
• Device Lot Number: 9772445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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: Required Intervention
• Patient Age: 76 YR