MAUDE Adverse Event Report: COOK INC C-FLEX MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15532
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k162104.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, during a stent insertion via the bladder using a c-flex multi-length ureteral stent set, the stent fractured at the distal end "on the perforation".It is unknown how the procedure was completed.No section of the device remains inside of the patient.No adverse effects were reported due to the alleged malfunction.Additional patient and event information has been requested.No other information is available at this time.A follow up report will be submitted when additional information is received.
Additional Manufacturer Narrative
After receipt of the complaint device and initial observation, it was noted that there was no fracture of the stent device.Therefore, no reportable device malfunction or serious injury occurred, and this complaint is now considered nonreportable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 since the last report was submitted.
Additional Manufacturer Narrative
The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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
Additional information received on 03feb2020: the fracture was discovered upon inspection of the stent as it was removed from the packaging at the scrub table.The procedure was successfully completed by using another stent.

• Brand Name: C-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9626691
• Report Number: 1820334-2020-00192
• Device Sequence Number: 11483971
• Product Code: FAD
• UDI-Device Identifier: 00827002155329
• UDI-Public: (01)00827002155329(17)211024(10)9258631
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 10/24/2021
• Device Model Number: G15532
• Device Catalogue Number: 036300
• Device Lot Number: 9258631
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/27/2020; 02/27/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/27/2020; 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1