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

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: fad stent, ureteral, product code: fad.(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
The customer reported that after an intended ureteroscopic lithotripsy (ursl) procedure, the physician tried to put filiform double pigtail ureteral stent set on the right side kidney and found that the pigtail of the stent set was cut off.Therefore, the physician removed the stent from the kidney.The physician completed the procedure using universal soft ureteral stent set.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: two open packages label lot on both packages; each set returned in the shipping tray.One returned set had a stent coil loose in the tray.The proximal coil had been severed and the tether was not returned with the stent.The coil was torn starting at the first sideport extending through the tip.The coil was torn by the tether during removal.The point of separation appeared cut and pulled to separation.Based on the investigation evaluation, 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.This complaint is confirmed based on the physical evaluation of the returned device.A review of the device history record found 2 other non-conformances associated with the complaint device lot number, however these non-conformances were not related to the reported failure.Based on the provided information the root cause is related to product use or handling.Per the quality engineering risk assessment no further action is required.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6622265
• Report Number: 1820334-2017-01083
• Device Sequence Number: 16294196
• Product Code: FAD
• UDI-Device Identifier: 00827002151451
• UDI-Public: (01)00827002151451(17)190826(10)7229015
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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 Model Number: N/A
• Device Catalogue Number: 133624
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR