MAUDE Adverse Event Report: COOK INC FLEXOR URETERAL ACCESS SHEATH AND DILATORS; FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY

Catalog Number FUS-107035

Device Problem Flaked (1246)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/03/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter: occupation = non-healthcare professional - unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a ureteroscopy with laser lithotripsy and using a flexor ureteral access sheath and dilators, pieces of the 10.7fr x 35cm access sheath tore off and had to be removed from the patient.Overall the procedure was noted to have run routinely.After placing the access sheath, the physician went up with a semirigid scope before switching to a flexible scope.They then lasered the stone and extracted the pieces with a basket.The physician believed it was possible they scraped the side of the sheath with the scope and other devices, thus wearing down the lining.Only one piece, approximately 3-4cm was completely separated from the sheath.There was a large piece that was still attached and located at the end of the sheath.Additional patient and event information has been requested.

Manufacturer Narrative

Event summary: as reported, during a ureteroscopy with laser lithotripsy and using a flexor ureteral access sheath and dilators, pieces of the 10.7fr x 35cm access sheath tore off and had to be removed from the patient.Overall the procedure was noted to have run routinely.After placing the access sheath, the physician went up with a semirigid scope before switching to a flexible scope.They then lasered the stone and extracted the pieces with a basket.The physician believed it was possible they scraped the side of the sheath with the scope and other devices, thus wearing down the lining.Only one piece, approximately 3-4cm was completely separated from the sheath.There was a large piece that was still attached and located at the end of the sheath.Investigation - evaluation: reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.As no lot information was provided, reviews of the device history record and complaint history could not be executed.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state, ¿prior to placement, activate the hydrophilic coating by removing the dilator from the flexor sheath and immersing all components in sterile water or isotonic saline.This will allow the hydrophilic surface to absorb water and become lubricious, easing placement under standard conditions.¿ based on the available information, cook has concluded that it is likely the inside of the sheath was damaged by the use of a semi-rigid scope during the procedure.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR URETERAL ACCESS SHEATH AND DILATORS
• Type of Device: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12869464
• MDR Text Key: 281209945
• Report Number: 1820334-2021-02569
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FUS-107035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2022
• 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): Required Intervention