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

Model Number	G34873
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer line 2: avenue des sables, la chauvelliere / customer email: (b)(6) e3: 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 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 or Problem Description
As reported, while extracting stone fragments during a flexible ureteroscopy, plastic filaments came loose from inside the sheath of a 'flexor parallel ureteral access sheath and dilator'.A flexible ureteroscope was passed through the sheath during use.The user wore latex gloves and did not report any difficulty advancing the device.The device was placed using the 'traditional' method.The hydrophilic coating was activated with water for 10-15 minutes; the dilator was not removed from the sheath during activation.The device was in use approximately 10 minutes.The procedure was completed using another access sheath.A section of the device did not remain inside the patient¿s body; nothing had to be removed from the patient's body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: d4- model#.Investigation ¿ evaluation as reported, while extracting stone fragments during a flexible ureteroscopy, plastic filaments came loose from inside the sheath of a 'flexor parallel ureteral access sheath and dilator'.A flexible ureteroscope was passed through the sheath during use.The user wore latex gloves and did not report any difficulty advancing the device.The device was placed using the 'traditional' method.The hydrophilic coating was activated with water for 10-15 minutes; the dilator was not removed from the sheath during activation.The device was in use approximately 10 minutes.The procedure was completed using another access sheath.A section of the device did not remain inside the patient¿s body; nothing had to be removed from the patient's body.The patient did not require any additional intervention or experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use, as well as visual inspection of the returned device, were conducted during the investigation.The complaint device was returned in an open package with a label.Upon inspection, no significant damage to the device was noticed.Some plastic filament/strings were found to be loose in the package.The dilator transitioned through the sheath without issue.Additionally, 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 (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the product ifu, t_flxr_rev5 specifies that 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.The information provided stated the dilator was not removed from the sheath when activating the coating.Evidence gathered upon review of complaint file, dhr, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a failure to follow instructions likely contributed to the event.The returned device was found to have no damage, but shavings from the inner diameter of the dilator were returned with the device.The information provided stated the dilator was not removed from the sheath when activating the coating.This likely could have prevented the fluid from reaching the coating on the inside of the dilator.Coating that was not activated then likely was scrapped off when other devices were inserted through the sheath.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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 PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: 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: 19647393
• Report Number: 1820334-2024-00889
• Device Sequence Number: 6578811
• Product Code: FED
• UDI-Device Identifier: 00827002348738
• UDI-Public: (01)00827002348738(17)270219(10)15906150
• Combination Product (Y/N): N
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: G34873
• Device Catalogue Number: FUS-107035-P
• Device Lot Number: 15906150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACTOR; FLEXIBLE URETEROSCOPE; WIRE GUIDE
• Patient Sex: Unknown