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

Model Number	G14906
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: pre-amendment.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 that during the kidney transplant procedure, a sof-flex pediatric double pigtail ureteral stent set was opened on the field.The scrub person was re-adjusting the stent onto the wire when it was noted the end of the stent had a cut on the side which was measuring about 1.5cm long.Another stent was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures 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: a visual inspection of the returned device was performed.A review of complaint history, the device history record, and specifications was also conducted.One open package labeled rpn 039512 with label lot number 8517011 was received.Only the positioner and wire guide were returned.The stent was not returned.Visual examination of the wire guide and positioner confirmed no physical damage or manufacturing anomalies with the returned components.A review of the device history record found there were no non-conformances noted related to the reported failure.A review of complaint history revealed this complaint to be the only complaint associated with the complaint device lot number 8517011.An incomplete set of components was returned.The wire guide and positioner were returned and a physical examination of these components identified they met manufacturing specifications.The stent component which is the subject of the complaint was not returned.A review of other complaints on this product line with a similarly described failure mode concluded that it is possible that the stent was torn by the tether that is attached to the device.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: SOF-FLEX PEDIATRIC 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: 7500398
• Report Number: 1820334-2018-01317
• Device Sequence Number: 2052975
• Product Code: FAD
• UDI-Device Identifier: 00827002149069
• UDI-Public: (01)00827002149069(17)210117(10)8517011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: Health Professional
• Device Model Number: G14906
• Device Catalogue Number: 039512
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1