MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Difficult to Advance (2920)

Patient Problem Pain (1994)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

According to the medsun report submitted by the user facility: event desc: stent would not advance with the guide wire.The guide wire was going through larger holes in the stent.It was not coiling in the bladder correctly.Patient pain also increases urge to urinate, requiring medication.This has reportedly occurred multiple times - md reports lot of friction and procedure takes longer.What was the original intended procedure? cysto rp with stent insertion.

Manufacturer Narrative

Lot # requested but not provided.(b)(4).Investigation- a review of the complaint history, instructions for use (ifu), manufacturing instructions (mi), quality control (qc and trends was conducted for the purpose of this investigation.No product nor the lot number were returned to assist with this investigation.Manufacturing controls include detailed manufacturing instruction and inspection procedure for proper length and curl diameter.This product is manufactured to specification per mi.Additional processing controls include inspection per qc and has inspection for both the product length and curl dimensions.The ifu for the product used in this case details the proper placement procedure and guidance that: "accurate measurement enhances drainage efficiency and patient comfort.".Multiple factors could have contributed to the incorrect coil and pain, including not adhering to the placement instructions within the ifu and improper sizing of the stent based on patient anatomy.However, based on the limited available information a definitive root cause can not be determined or reported at this time.We will continue to monitor for similar complaints.Additional action is not required at this time, the residual risk remains at an acceptable level.

Event Description

According to the medsun report submitted by the user facility: event desc: stent would not advance with the guide wire.The guide wire was going through larger holes in the stent.It was not coiling in the bladder correctly.Patient pain also increases urge to urinate, requiring medication.This has reportedly occurred multiple times - md reports lot of friction and procedure takes longer.What was the original intended procedure: cysto rp with stent insertion.

• Brand Name: UNIVERSA SOFT URETERAL 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: 5260714
• MDR Text Key: 32552940
• Report Number: 1820334-2015-00815
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2015,11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: USH-624-RT1
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2015
• Distributor Facility Aware Date: 10/09/2015
• Event Location: Hospital
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other