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

Catalog Number FUS-120045

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2022

Event Type  malfunction  

Event Description

As reported, the patient was hospitalized on (b)(6) 2022 with kidney stones.On (b)(6) 2022, a laser lithotripsy for ureteral (soft) kidney stones was performed using a flexor ureteral access sheath and dilators.During the procedure, the user found a "transparent shadow" when an unspecified ureteral catheter was inserted into the patient.The catheter was removed and replaced, and a "plastic film" was found in the flexible sheath.Upon removal and examination, the film was approximately 20 centimeters in length and showed a "fine filamentous shape".At this time, it is unknown how the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Manufacturer Narrative

Customer address: (b)(6).Customer occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received 29jan2023.The coating of the sheath was activated with saline and an unspecified holmium laser was used through the sheath.Upon removal of the sheath, the "film" noted was attached to the sheath and the same sheath was used to complete the procedure.

Event Description

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

Manufacturer Narrative

Correction: h6 (annex g).Event description as reported, the patient was hospitalized on (b)(6) 2022 with kidney stones.On (b)(6) 2022, a laser lithotripsy for ureteral (soft) kidney stones was performed using a flexor ureteral access sheath and dilators.The coating of the sheath was activated with saline and an unspecified holmium laser was used through the sheath.During the procedure, the user found a "transparent shadow" when an unspecified ureteral catheter was inserted into the patient.The catheter was removed and replaced, and a "plastic film" was found in the flexible sheath; the film noted was attached to the sheath.Upon removal and examination, the film was approximately 20 centimeters in length and showed a "fine filamentous shape".The same sheath was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there was no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.The product ifu provides the following information to the user: note: 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, no product returned, and the results of the investigation, it is possible that other devices used during the procedure scraped the inner lining of the sheath.However, not enough information was known to allow the cause to be conclusively determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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: 16215579
• MDR Text Key: 308947170
• Report Number: 1820334-2023-00042
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 10827002461687
• UDI-Public: (01)10827002461687(17)250223(10)14553026
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FUS-120045
• Device Lot Number: 14553026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: 78 YR
• Patient Sex: Male