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

Model Number	G09601
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	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: name and address - postal code: 3010.E3: occupation: materiovigilence.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 percutaneous transluminal angioplasty crossover procedure, a flexor introducer sheath's check-flo valve separated.Access was obtained through the right femoral artery for contralateral approach.The access site was not scarred, and the patient's anatomy was not stenosed, tortuous or calcified.The bifurcation angle was not steep or calcified.The sheath was advanced over another manufacturer's wire guide and was "easy" to insert.The intervention was completed without any problems, however; upon removal of the sheath (with the wire in place), the hub tore off.The dilator was not in place upon removal of the sheath, and the sheath hub was used for removal.Resistance was not felt upon advancement or removal of the sheath nor advancement/removal of the wire, unknown manufacturer's catheter/dilation balloon through the sheath.The sheath was able to be removed endovascularly, as the doctor pulled the remaining sheath.The procedure was completed successfully.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: d4 summary of event: as reported, during a percutaneous transluminal angioplasty crossover procedure, a flexor introducer sheath's check-flo valve separated.Access was obtained through the right femoral artery for contralateral approach.The access site was not scarred, and the patient's anatomy was not stenosed, tortuous or calcified.The bifurcation angle was not steep or calcified.The sheath was advanced over another manufacturer's wire guide and was "easy" to insert.The intervention was completed without any problems, however; upon removal of the sheath (with the wire in place), the hub tore off.The dilator was not in place upon removal of the sheath, and the sheath hub was used for removal.Resistance was not felt upon advancement or removal of the sheath nor advancement/removal of the wire, unknown manufacturer's catheter/dilation balloon through the sheath.The sheath was able to be removed endovascularly, as the doctor pulled the remaining sheath.The procedure was completed successfully.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.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 was conducted as well.The complaint device was returned to cook for investigation.The sheath was received already pulled free from the hub and there was no sheath material left inside the hub.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿warnings: if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance i anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.Precautions: in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.Sheath removal: 1.Insert a wire guide until its tip extends at least 10cm past the tip of the sheath.2.Remove the sheath.Avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.3.Remove the wire guide.¿ 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, returned device, and complaint file suggests that there is evidence the device was 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 component failure unrelated to manufacturing or design deficiencies contributed to this incident.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 INTRODUCER 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: 19654620
• Report Number: 1820334-2024-00891
• Device Sequence Number: 15159143
• Product Code: DYB
• UDI-Device Identifier: 00827002096011
• UDI-Public: (01)00827002096011(17)251208(10)15114645
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Expiration Date: 12/08/2025
• Device Model Number: G09601
• Device Catalogue Number: KCFW-8.0-38-45-RB
• Device Lot Number: 15114645
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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: TERUMO .035X180CM GLIDEWIRE.
• Patient Sex: Unknown