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

Model Number G34874

Device Problem Flaked (1246)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Name and address: postal code: (b)(6).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, while using a flexor parallel ureteral access sheath and dilators, they discovered fiber-like matter inside of the sheath lumen.The procedure was to extract kidney stones, and the user had inserted the device into the scope several times to perform the extraction.They removed it from the sheath lumen and replaced it with another device from the same lot.The fiber-like matter was also discovered in this device.They replaced it with a device from another manufacturer to successfully complete the procedure.They confirmed the fiber-like matter was not left inside of the patient's body.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Summary of event: as reported, while using a flexor parallel ureteral access sheath and dilators, they discovered fiber-like matter inside of the sheath lumen.The procedure was to extract kidney stones, and the user had inserted the device into the scope several times to to perform the extraction.They removed it from the sheath lumen and replaced it with another device from the same lot.The fiber-like matter was also discovered in this device.They replaced it with a device from another manufacturer to successfully complete the procedure.They confirmed the fiber-like matter was not left inside of the patient's body.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu) and quality control procedures were conducted during the investigation.A visual inspection of the returned complaint devices was also conducted.Two devices with outer packages were returned to cook for investigation.A tube containing the plastic shavings was also returned.One of the returned sheaths had delamination at the distal tip and a long shredded material is wrapped around the inside of the tip.The second sheath has tip delamination, but not as visible.The material inside the returned tube is most likely from the second sheath.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in 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 instructions for use (ifu) provides the following information to the user related to the reported failure mode: 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, it is likely the sheaths were damaged during use by the instruments inserted through them during the procedure.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 PARALLEL 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: 13175210
• MDR Text Key: 289212023
• Report Number: 1820334-2022-00026
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00827002348745
• UDI-Public: (01)00827002348745(17)230313(10)13050866
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: G34874
• Device Catalogue Number: FUS-107045-P
• Device Lot Number: 13050866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• 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
• Treatment: BOSTON SCIENTIFIC¿S ZERO TIP BASKET; OLYMPUS¿ V2 SCOPE; TAKAI¿S 272 M LASER FIBER
• Patient Sex: Male