MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; KOE DILATOR, URETHRAL

Model Number N/A

Device Problems Component Falling (1105); Flaked (1246); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a ureteroscopy procedure, the ptfe coating inside of the device was stripping off inside of the patient.Using an engage grasper, the physician was able to remove some of the fragments from the patient, however, some smaller fragments remain.No harm to the patient has been reported and no additional procedures were scheduled.Additional information has been requested, however it was not available at the time of this report.

Manufacturer Narrative

(b)(4).Event evaluation: one fus-095028 was returned from an unknown lot.(it should be noted that only the sheath was returned).A visual examination along with a review of complaint history, trends and quality control was conducted during the investigation.The returned sheath was visually inspected; which revealed no damage to the outer shaft of the sheath.An endoscope was used to inspect the inside of the flexor sheath; which confirmed that the inner lumen of the sheath was shredding off of the sheath.Based on the appearance of the delamination, it appeared as if something had scraped the inside of the sheath causing the delamination in two locations near the distal end of the sheath.There is no evidence to suggest that the device was not made to specification.The root cause could not be definitively determined, however, it is likely that another device caused the inner lumen to shred.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.Quality engineering risk assessment was used to assess the risk of this failure mode.The risk remains acceptable; therefore, no risk mitigation activities are required at this time.

Event Description

During a ureteroscopy procedure, the ptfe coating inside of the device was stripping off inside of the patient.Using a cook engage grasper, the physician was able to remove some of the fragments from the patient, however, some smaller fragments remain.No harm to the patient has been reported and no additional procedures were scheduled.Additional information has been requested, however it was not available at the time of this report.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Type of Device: KOE DILATOR, URETHRAL
• 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: 5214175
• MDR Text Key: 30884215
• Report Number: 1820334-2015-00732
• Device Sequence Number: 1
• Product Code: KOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• 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: FUS-095028
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2015
• Event Location: Hospital
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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