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

Model Number	G34874
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
As reported, during a flexible ureteroscopy, a flexor parallel ureteral access sheath and dilator's sheath peeled off during a kidney stone extraction.The device was placed using the "traditional method" and was in place between 30 and 60 minutes.Latex gloves were worn and the coating was activated with "serum phy/water." the sheath was removed and replaced with another device.A section of the device did not remain inside the patient¿s body.The patient did not require additional procedures due to this occurrence.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.
Additional Manufacturer Narrative
Event summary: as reported, during a flexible ureteroscopy, a flexor parallel ureteral access sheath and dilator's sheath peeled off during a kidney stone extraction.The device was placed using the "traditional method" and was in place between 30 and 60 minutes.Latex gloves were worn and the coating was activated with "serum phy/water." the sheath was removed and replaced with another device.A section of the device did not remain inside the patient¿s body.The patient did not require additional procedures due to this occurrence.According to the initial reporter, the patient did not experience adverse effects due to this occurrence.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, and quality control data.A device failure analysis was conducted on the returned device.Product was returned with label but no packaging.The set was not complete as the dilator was not returned.Upon inspection, peeling was noted from the inside at the distal end of the 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 complaint history records shows no other complaints associated with the complaint device lot.The returned device was found to have filaments of clear inner sheath material extending out of the distal end of the sheath.The dilator component was not returned.All devices are inspected for occlusions during quality control checks.The most likely cause for the issue is that one of the objects placed through the sheath peeled the inner lining off during use.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 or Problem Description
No new patient or event information since the last report was submitted.

• 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 ; 8128294891
• MDR Report Key: 13515093
• Report Number: 1820334-2022-00203
• Device Sequence Number: 4207166
• Product Code: FED
• UDI-Device Identifier: 00827002348745
• UDI-Public: (01)00827002348745(17)241122(10)14371071
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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 Expiration Date: 11/22/2024
• Device Model Number: G34874
• Device Catalogue Number: FUS-107045-P
• Device Lot Number: 14371071
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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: .35 TERUMO WIRE; RIGID URETEROSCOPE
• Patient Sex: Unknown