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

Model Number	G49045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: name and address - phone: (b)(6).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 an iliac branch implantation procedure involving placement of another manufacturer¿s stent into the internal iliac artery, the hub of a flexor high-flex ansel guiding sheath separated from the device.Contralateral access was obtained, and an unspecified cook 12-french ansel sheath was placed up-and-over the bifurcation.The anatomy was reportedly angulated and very tortuous over the bifurcation.Calcification was not noted.The 8-french complaint device was easily inserted and advanced coaxially, over an unspecified amplatz wire guide, through the 12-french sheath.Another manufacturer¿s stent delivery system was easily inserted and advanced through the complaint device, over the wire.After the stent was positioned in the internal iliac artery, the user attempted to pull the complaint device back to deploy the stent, using the hub to pull the sheath.Per the reporter, ¿everything was tight¿ and the internal iliac artery was very angulated; therefore, the physician had to use ¿an excessive amount of force¿ to pull the sheath back, at which point the hub separated, resulting in ¿a lot¿ of blood loss.The stent was quickly deployed, and the complaint device was removed manually from the 12-french sheath, with the stent delivery system still in the complaint device.The dilator was not reinserted for removal, as the other manufacturer¿s delivery system was firmly wedged in the sheath lumen.The procedure was completed successfully, and no part of the complaint device remained in the patient¿s body.The patient received crystalloid fluid replacement for blood loss.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an iliac branch implantation procedure involving placement of another manufacturer¿s stent into the internal iliac artery, the hub of a flexor high-flex ansel guiding sheath separated from the device.Contralateral access was obtained, and an unspecified cook 12-french ansel sheath was placed up-and-over the bifurcation.The anatomy was reportedly angulated and very tortuous over the bifurcation.Calcification was not noted.The 8-french complaint device was easily inserted and advanced coaxially, over an unspecified amplatz wire guide, through the 12-french sheath.Another manufacturer¿s stent delivery system was easily inserted and advanced through the complaint device, over the wire.After the stent was positioned in the internal iliac artery, the user attempted to pull the complaint device back to deploy the stent, using the hub to pull the sheath.Per the reporter, ¿everything was tight¿ and the internal iliac artery was very angulated; therefore, the physician had to use ¿an excessive amount of force¿ to pull the sheath back, at which point the hub separated, resulting in ¿a lot¿ of blood loss.The stent was quickly deployed, and the complaint device was removed manually from the 12-french sheath, with the stent delivery system still in the complaint device.The dilator was not reinserted for removal, as the other manufacturer¿s delivery system was firmly wedged in the sheath lumen.The procedure was completed successfully, and no part of the complaint device remained in the patient¿s body.The patient received crystalloid fluid replacement for blood loss.Investigation evaluation: reviews of the complaint history, device history record (dhr), 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.The hub was separated, with no sheath material remaining in the hub.The sheath flare was intact.A catheter was lodged inside the sheath, and upon attempted removal of the catheter, it broke/separated, leaving a portion of the catheter in the sheath.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 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 ifu also states ¿avoid applying traction to hub during removal.¿ 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.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 the patient¿s anatomy and unintended user error contributed to this event.The anatomy was reportedly very tortuous and angulated over the bifurcation.Upon withdraw of the sheath, the user reported that ¿everything was tight¿ and an ¿excessive amount¿ of force was used to pull the sheath back.The user also pulled the sheath by the hub, which the ifu instructs to avoid.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 HIGH-FLEX 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: 20536759
• Report Number: 1820334-2024-01408
• Device Sequence Number: 8325270
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)270424(10)16026629
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G49045
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL1-HC
• Device Lot Number: 16026629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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 10MM X 79MM STENT 8FR; UNKNOWN MANUFACTURE'S AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male