MAUDE Adverse Event Report: COOK INC SALLE PYELOPLASTY STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2017

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

Report received via fda - medsun report (b)(4) stating "the white connector on the salle stent was not working properly." additional information provided by the customer indicates that the white connector was replaced.The connector was in use for less than one day.There are no reported adverse patient consequences.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.

Manufacturer Narrative

Investigation summary: one connecting tube and 050010 were received.The stent and remaining set components were not returned.Connecting tube ctu-10-30-nstc and 050010 adapter are part of the set for sipsf-040018-5.9.The end of the connecting tube had a 050010 adapter attached to the male luer lock adapter (mlla).The adapter did not have a black o-rings inside the cap.During investigation, it was found out that the missing o ring in the adapter caused the customer's difficulty.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.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on the investigation evaluation, there is an indication that a process-related failure mode contributed to this event, however a specific root cause could not be determined.Relevant personnel have been notified and monitoring of this complaint issue has been instituted.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: SALLE PYELOPLASTY STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6748294
• MDR Text Key: 81315573
• Report Number: 1820334-2017-01863
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002327733
• UDI-Public: (01)00827002327733(17)200418(10)7839187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SIPSF-040018-59
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 YR