MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
During an intended cystoscopy with stent exchange procedure on a patient, the customer found that the tether ripped free from the distal end of the filiform double pigtail ureteral stent set when the package was opened.The device did not come in contact with the patient.The procedure was completed by placing another filiform double pigtail ureteral stent set.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of complaint history, the device history record, quality control data and specifications was performed.A visual examination of the returned stent was also conducted.The stent was returned with a peel off label confirming the rpn 133824 and label lot number 7679519.Stent and tether was returned in two separate pieces.Tether has been pulled out of the stent.The stent proximal coil was torn starting at the last side port and continued through the end of the stent.The tether was returned in one continuous unbroken piece.The tether has been removed from the stent; excessive pressure applied to the tether during removal has torn the stent coil.There is no evidence of any manufacturing anomalies that would contribute to this event.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record found no other non-conformances associated with the complaint device lot number.A review of complaint history for this product/lot number combination did not reveal any other complaints to be associated with the complaint device lot.Based on the information provided and returned device analysis, the definitive root cause is related to product use and applying excessive pressure on the device.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6587608
• Report Number: 1820334-2017-01054
• Device Sequence Number: 13471469
• Product Code: FAD
• UDI-Device Identifier: 00827002151284
• UDI-Public: (01)00827002151284(17)200215(10)7679519
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: 133824
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1