MAUDE Adverse Event Report: COOK INC FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
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 peripheral endovascular intervention and angioplasty of the superficial femoral artery, two flexor ansel guiding sheaths were found to be leaking at the valve.Access was gained through the common femoral artery.The anatomy was calcified.Heparin was given during the procedure.Resistance was not reported.The first sheath began leaking, described as "almost squirting", but was removed immediately, within one minute.A second flexor ansel guiding sheath was then placed and found to leak, but the user decided to finish the procedure with the second device, which was in place for approximately 4.5 hours, despite a continual drip.The dilators were not in place during removal of the devices.Although blood loss was reported, no intervention was required for blood loss.The procedure was completed successfully.No portion of the device was left inside the patient.This did not result in additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Summary of event: as reported, during a peripheral endovascular intervention and angioplasty of the superficial femoral artery, two flexor ansel guiding sheaths were found to be leaking at the valve.Access was gained through the common femoral artery.The anatomy was calcified.Heparin was given during the procedure.Resistance was not reported.The first sheath began leaking, described as "almost squirting", but was removed immediately, within one minute.A second flexor ansel guiding sheath was then placed and found to leak, but the user decided to finish the procedure with the second device, which was in place for approximately 4.5 hours, despite a continual drip.The dilators were not in place during removal of the devices.Although blood loss was reported, no intervention was required for blood loss.The procedure was completed successfully.No portion of the device was left inside the patient.This did not result in additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, trends, and personnel interview were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.Two devices were returned to cook for investigation.One sheath was returned with a 0.038" dilator inserted.No visible damage to the sheaths or dilator was observed.Both sheaths were leak tested and leakage from the silicone discs was confirmed.The check-flo caps were removed and the silicone discs were examined.No damage nor tears were found.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.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 lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field and that the complaint lot was manufactured to current specifications.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package and to flush the sheath prior to use.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that device failure contributed to the event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10644920
• Report Number: 1820334-2020-01817
• Device Sequence Number: 1178553
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)230605(10)13229672
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 06/05/2023
• Device Model Number: N/A
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13229672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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: UNKNOWN MANUFACTURER 018 AND 014 BALLOONS; UNKNOWN MANUFACTURER 035 AND 018 CATHETERS; UNKNOWN MANUFACTURER 035, 018 AND 014 WIRES