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

Model Number	G44155
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during percutaneous transluminal angioplasty to open a narrow lesion within the superficial femoral artery (sfa), the hub of a flexor ansel guiding sheath separated.Per the reporter, it was difficult to cross the ¿critical¿ lesion within the sfa.After another manufacturer¿s balloon was used for angioplasty, the physician attempted to withdraw the balloon from the sheath; however, it was difficult to withdraw the balloon.When resistance was no longer felt, the physician found that the hub and ¿catheter body¿ were separated.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information has been requested.
Additional Manufacturer Narrative
E1: phone = (b)(6).H3: device evaluation anticipated, but not yet begun.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.
Additional Manufacturer Narrative
H3: device evaluation has begun; however, a conclusion is not 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
Additional information was received on 29jul2025 and 31jul2025.As reported, a contralateral approach was used to access from the common femoral artery to the lesion located in the contralateral common iliac artery.The access site was not scarred.The target lesion was stenosed and calcified.The bifurcation was calcified.Resistance was encountered when removing competitor's balloon from the sheath.The competitors' wire guide and balloon were in the lumen of the sheath during the separation.When the separation occurred, a part of sheath was still outside the patient's body and was removed "directly".
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 reported, during percutaneous transluminal angioplasty to open a narrow lesion within the superficial femoral artery (sfa), the hub of a flexor ansel guiding sheath separated.Per the reporter, it was difficult to cross the ¿critical¿ lesion within the sfa.After another manufacturer¿s balloon was used for angioplasty, the physician attempted to withdraw the balloon from the sheath; however, it was difficult to withdraw the balloon.When resistance was no longer felt, the physician found that the hub and ¿catheter body¿ were separated.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information was received on 29jul2025 and 31jul2025.As reported, a contralateral approach was used to access from the common femoral artery to the lesion located in the contralateral common iliac artery.The access site was not scarred.The target lesion was stenosed and calcified.The bifurcation was calcified.Resistance was encountered when removing competitor's balloon from the sheath.The competitors' wire guide and balloon were in the lumen of the sheath during the separation.When the separation occurred, a part of sheath was still outside the patient's body and was removed "directly".Corrected information: d4 (udi).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The hub was separated from the sheath, with no sheath material remaining in the hub.The sheath flare was damaged.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional complaints on the final or sub-assembly lots.The product ifu cautions ¿all interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ 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 device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this event.The other manufacturer¿s balloon was not returned to cook.Although it is possible that compatibility issues between the sheath and balloon may have contributed to this event, this cannot be definitively determined.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: 22522705
• Report Number: 1820334-2025-00853
• Device Sequence Number: 8011233
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)270328(10)15980444
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2026

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: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 15980444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 01/06/2026
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/08/2025; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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: BOSTON MUSTANG PTA BALLOON.; TERUMO RADIFOCUS .035" GUIDEWIRE.
• Patient Sex: Unknown