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

Model Number	G34880
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
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.
Event or Problem Description
As reported, during a left ureteroscopy, laser lithotripsy, and stone removal with basket procedure using a flexor ureteral access sheath and dilators, the device frayed upon removal from the patient.The device frayed in the lumen of the ureteral access sheath.The issue was first noticed near the end of the procedure after several passes with the stone basket.The device was in place for 75 minutes.The procedure was completed without any device fragment being left in the patient's body.No additional intervention was required as a result of this occurrence.Following the procedure, the patient was discharged to a nursing home but was taken to the emergency department later that day for fevers, change in mentation, and acute agitation.The patient was admitted to the icu for 34 hours before being discharged back to the nursing home.The reported device malfunction is not suspected to have caused or contributed to these symptoms or subsequent icu admission.The patient did not experience any adverse effects due the reported malfunction.
Additional Manufacturer Narrative
Event summary: as reported, during a left ureteroscopy, laser lithotripsy, and stone removal with basket procedure using a flexor ureteral access sheath and dilators, the device frayed upon removal from the patient.The device frayed in the lumen of the ureteral access sheath.The procedure was completed without any device fragment being left in the patient's body.Following the procedure, the patient was discharged to a nursing home but was taken to the emergency department later that day for fevers, change in mentation, and acute agitation and admitted to the icu for 34 hours before being discharged.The reported device malfunction is not suspected to have caused or contributed to these symptoms or subsequent icu admission.The patient did not experience any adverse effects due the reported malfunction.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and dimensional verification of the device were conducted during the investigation.One fus-107045 access sheath was returned for investigation in a used condition.The dilator was not returned.Visual examination noted a dried substance on the outside of the access sheath.The sheath was returned with a bowed appearance.The sheath overall length was 44.5 cm.No damage was visible on the proximal end.The distal tip did not appear to be frayed.No damage was noted to the inner wall of the sheath.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions and quality control procedures.Current controls are in place to mitigate the occurrence of this failure mode by inspecting the device prior to device distribution.Evaluation of the returned device notes no fraying on the distal or proximal ends.Visual inspection of the device inner wall shows no scratches or damage.The failure could not be replicated.Based on the available information, cook has concluded that a cause for this event could not be determined.Cook will continue monitoring of similar complaints and have 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 or Problem 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
• Common Device Name: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10918807
• Report Number: 1820334-2020-02186
• Device Sequence Number: 2758316
• Product Code: FED
• UDI-Device Identifier: 00827002348806
• UDI-Public: (01)00827002348806(17)230723(10)13324077
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 07/23/2023
• Device Model Number: G34880
• Device Catalogue Number: FUS-107045
• Device Lot Number: 13324077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC SENSOR WIRE STRAIGHT TIP; HALO STONE BASKET; BOSTON SCIENTIFIC SENSOR WIRE STRAIGHT TIP; HALO STONE BASKET
• Patient Age: 69 YR
• Patient Weight: 102