MAUDE Adverse Event Report: COOK INC ENDO-SOF AQ DOUBLE PIGTAIL STENT SET; FAD STENT, URETERAL

Catalog Number DPSCS-050022-AQ-R

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2017

Event Type  malfunction  

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 Description

The user facility reported the pigtail of the endo-sof aq double pigtail stent set was found broken prior to patient contact.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a visual examination and dimensional verification of the returned device was conducted.A review of complaint history, the device history record, drawings, and specifications was also performed.One open package labeled rpn dpscs-050022-aq-r and label lot 8099094 was received.A 5 fr 22cm stent and a 4.7 fr positioner were returned.The stent was returned without the tether.The proximal coil is smashed flat in two locations.A hsf-35-50-qc wire guide would not transition through the damaged coil.This stent set is packaged in a stent tray, placing each set component into their respective location within the tray and secured by snapping the lid closed.The coil damage is consistent with being trapped between the lid closure and tray.Due to the package being open and the stent being manipulated, it cannot be definitively determined if manufacturing process, operator error, or procedural /clinical factors contributed to this event.A review of the device history record found no 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 this device lot number 8099094.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information the root cause of this issue cannot be determined.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: ENDO-SOF AQ DOUBLE PIGTAIL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7120449
• MDR Text Key: 95386294
• Report Number: 1820334-2017-04434
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002179219
• UDI-Public: (01)00827002179219(17)200727(10)8099094
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: DPSCS-050022-AQ-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 73