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

Model Number	G29985
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluated by mfg: other (81) - device evaluation has begun; however, a conclusion is not yet available.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 originally reported, during an unspecified procedure, another manufacturer's stent was difficult to insert into two flexor ansel guiding sheaths.Per the reporter, the stent was meant for use with a 7-french sheath, and the dilators were easily advanced into the sheaths.Contralateral access was obtained in the right side to target the left common iliac artery.The anatomy was stenosed.The user encountered a "great deal" of resistance when attempting to insert the stent through the first sheath; therefore, the stent was removed, and the sheath was exchanged for a new device from the same lot; however, the user was not able to advance the stent all the way through the second sheath.Per the reporter, the second sheath and the stent system became "bonded together" and were returned to the manufacturer of the stent.Unknown wire guides and unspecified cook catheters were also used through the sheaths during the procedure.An unspecified 8-french sheath and a new stent were used to complete the procedure.Nothing remained in the patient's body.The patient did not require hospitalization or additional procedures due to this event.There were no adverse effects to the patient.One sheath was returned to cook on 29aug2024.The sheath had delaminated.
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
Summary of event: as originally reported, during an unspecified procedure, another manufacturer¿s stent was difficult to insert into two flexor ansel guiding sheaths.Per the reporter, the stent was meant for use with a 7-french sheath, and the dilators were easily advanced into the sheaths.Contralateral access was obtained in the right side to target the left common iliac artery.The anatomy was stenosed.The user encountered a ¿great deal¿ of resistance when attempting to insert the stent through the first sheath; therefore, the stent was removed, and the sheath was exchanged for a new device from the same lot; however, the user was not able to advance the stent all the way through the second sheath.Per the reporter, the second sheath and the stent system became ¿bonded together¿ and were returned to the manufacturer of the stent.Unknown wire guides and unspecified cook catheters were also used through the sheaths during the procedure.An unspecified 8-french sheath and a new stent were used to complete the procedure.Nothing remained in the patient¿s body.The patient did not require hospitalization or additional procedures due to this event.There were no adverse effects to the patient.One sheath was returned to cook on 29aug2024.The sheath had delaminated.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of a complaint device was also conducted.One complaint device was returned to cook for investigation.Delamination was noted in the sheath flare and several pieces of inner sheath liner were also returned.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final or sub-assembly lots.A review of complaint history found no additional relevant complaints for this lot number, or any other lot associated with the same sub-assembly lots as the complaint devices.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the devices were manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.Although it is possible that the other manufacturer¿s stent may have caused the delamination, this cannot be confirmed.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.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• 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: 20202763
• Report Number: 1820334-2024-01213
• Device Sequence Number: 7517710
• Product Code: DYB
• UDI-Device Identifier: 00827002299856
• UDI-Public: (01)00827002299856(17)270215(10)15899089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: G29985
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 15899089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: GORE VBX STENT 8X2.5, VVJR080202A
• Patient Sex: Unknown