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

Catalog Number	KCFW-5.0-38-30-RB
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 reported, during a procedure involving angioplasty of the right iliac artery, a flexor introducer sheath unraveled upon attempted removal of another manufacturer's balloon catheter.Access was obtained in the left common femoral artery.The balloon had been deflated and negative pressure was maintained upon attempted removal of the other manufacturer's 5-french, 8x80 balloon catheter; however, the balloon catheter was not able to be pulled through the sheath.The sheath and balloon catheter were then removed together, over an unspecified stiff angled guide wire, without losing wire access.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the sheath, the sheath was unraveled and delaminated, with unraveled coils connecting separated sheath material.The other manufacturer's balloon catheter was lodged inside the sheath.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d10 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 30aug2023.The access site was not scarred; however, in-stent stenosis was present at the right external iliac artery, and the iliac bifurcation was calcified.The physician ballooned the right external iliac artery and the right common iliac artery.Another manufacturer's 0.035-inch, 260-centimeter stiff angled wire was used during the procedure.Resistance was not encountered upon insertion of the sheath; however, resistance was encountered upon removal of the device.
Additional Manufacturer Narrative
Summary of event: as reported, during a procedure involving angioplasty of the right iliac artery, a flexor introducer sheath unraveled upon attempted removal of another manufacturer's balloon catheter.Access was obtained in the left common femoral artery.The balloon had been deflated and negative pressure was maintained upon attempted removal of the other manufacturer's 5-french, 8x80 balloon catheter; however, the balloon catheter was not able to be pulled through the sheath.The sheath and balloon catheter were then removed together, over an unspecified stiff angled guide wire, without losing wire access.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the sheath, the sheath was unraveled and delaminated, with unraveled coils connecting separated sheath material.The other manufacturer's balloon catheter was lodged inside the sheath.Additional information was received 30aug2023.The access site was not scarred; however, in-stent stenosis was present at the right external iliac artery, and the iliac bifurcation was calcified.The physician ballooned the right external iliac artery and the right common iliac artery.Another manufacturer's 0.035-inch, 260-centimeter stiff angled wire was used during the procedure.Resistance was not encountered upon insertion of the sheath; however, resistance was encountered upon removal of the device.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), 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 with another manufacturer¿s device lodged inside the sheath.The shaft of the sheath was accordioned, and the sheath was separated at approximately 3.3-centimeters from the hub.Approximately 1.3-centimeters of the inner coil was visible.There was no damage noted to an unused device also returned from the customer.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.The product ifu warns ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ 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.There is no evidence of non-conforming devices in-house or in the field.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 the patient¿s calcified and stenosed anatomy contributed to this 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 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: 17641647
• Report Number: 1820334-2023-01165
• Device Sequence Number: 14872798
• Product Code: DYB
• UDI-Device Identifier: 00827002321946
• UDI-Public: (01)00827002321946(17)260424(10)15404297
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2023

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: 04/24/2026
• Device Catalogue Number: KCFW-5.0-38-30-RB
• Device Lot Number: 15404297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 10/27/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/15/2023; 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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: BARD ULTRAVERSE 5FR 8X80 0.035."; BARD ULTRAVERSE 8X80MM 75CM .035 BALLOON CATHETER.; TERUMO .035 X 260CM STIFF ANGLE GLIDEWIRE.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 102 KG