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

Model Number	G49942
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, after a rirs (retrograde intrarenal surgery) the physician was preparing to place a universa soft ureteral stent but noticed the pigtail had a crack.The cracked stent was not used, and the physician changed to a new device to finish the surgery.No adverse effects have been reported due to the alleged malfunction.
Additional Manufacturer Narrative
On (b)(6) 2020, cook was informed of an event involving a soft ureteral stent and positioner.The physician had completed a retrograde intrarenal surgery procedure and attempted to insert the stent.However, the physician noticed the tip of pigtail had a crack.To correct the issue, a second stent was used to finish the surgery.There was no harm to the patient as a result of the event.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, quality control data, and specifications.One device was returned for investigation.Visual examination confirmed that the stent and positioner only were returned in a prior to use condition.No damage was observed on the positioner.The tether was not returned with the stent.A tear was confirmed on the stent¿s proximal coil.Closer examination revealed the tear originated at the last side port measuring 1cm long.The tear continued through the end of the coil end.No other damage was found on the stent.A review of the device history record(dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were 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: device description a braided or monofilament tether for repositioning and removal of the device is located on the proximal pigatil of the stent.Precautions the tether should be removed if the stent is to remain indwelling longer than 14 days.How supplied upon removal from the package, inspect the product to ensure no damage has occurred.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.The cause for the split observed in the proximal end of the stent is attributed to forceful removal of the tether.Per the quality engineering risk assessment, no further action is warranted.We 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.
Event or Problem Description
No new patient or event information to report.

• 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: 9672134
• Report Number: 1820334-2020-00292
• Device Sequence Number: 18920888
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)220122(10)9465290
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 9465290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1