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

Catalog Number UNKNOWN

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported many physicians are seeing an increase in universal soft ureteral stents appearing knotted upon removal.Additional information regarding the devices, events and patients is unknown.There were no adverse consequences to the patient as a result of this reported issue.

Manufacturer Narrative

Investigation ¿ evaluation: the complaint device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.The investigation included a review of the instructions for use, and specifications.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record could not be performed as the rpn and lot number of the device was not provided.A review of complaint history for this product lot was not able to be performed without the rpn and device lot number.The instructions for use (ifu) contains the following warning: formation of knots in multi-length stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.The part number of the product was not provided but based on a review of the sales to the customer it is most likely the device was either from the universa soft hydrophilic or the universa firm hydrophilic product lines.A document review of manufacturing processes did not find any anomalies.A search was carried out for additional complaints from the same facility, no other complaints had been reported for stent knotting.Due to the lack of information on the part number or lot number unused product was not pulled from stock for inspection.Based on the provided information a definitive root cause could not 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: 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: 7366331
• MDR Text Key: 103436226
• Report Number: 1820334-2018-00808
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 04/25/2018
• 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