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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address= phone: (b)(6) address line 2: (b)(6) postal code: (b)(6); 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 side branch procedure, the hub separated from an 8 french flexor high-flex ansel guiding sheath.The complaint device was used inside of a 12 french ansel sheath, together with another manufacturer's device, over an unspecified rosen wire, for deployment of another manufacturer's stent.While pulling the complaint device back for deployment of the other manufacturer's stent, unexpected high friction was encountered, and the sheath hub separated.The surgical procedure was prolonged, additional blood loss was reported, and additional material was needed to remove the broken sheath and other manufacturer's stent.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.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an iliac side branch procedure, the hub separated from an 8 french flexor high-flex ansel guiding sheath.The complaint device was used inside of a 12 french ansel sheath, together with another manufacturer's device, over an unspecified rosen wire, for deployment of another manufacturer's stent.While pulling the complaint device back for deployment of the other manufacturer's stent, unexpected high friction was encountered, and the sheath hub separated.The surgical procedure was prolonged, additional blood loss was reported, and additional material was needed to remove the broken sheath and other manufacturer's stent.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.Additional information was received 28jun2023.The complaint device and another manufacturer¿s sheath were placed inside of a 12french cook sheath at the same time, by puncturing the valve of the 12 french sheath.The sheath hub was used to pull the device from the patient.The dilator was not reinserted into the sheath prior to removal, as the rosen wire and other manufacturer¿s stent were still in the lumen of the sheath.The sheath was removed with a clamp.The patient required unspecified treatment for blood loss.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.The hub was separated from the sheath.No sheath material remained in the hub.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 states "if resistance is encountered during sheath advancement, 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.¿ the ifu also instructs ¿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.¿ 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 unintended user error contributed to this event.The user experienced unexpected high friction during sheath removal; however, the dilator was not reinserted to reduce the risk of sheath material or hub separation upon sheath withdrawal, as instructed in the ifu.The sheath was also reportedly pulled by the hub during removal, despite instructions to avoid application of traction to the hub in the ifu.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.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
Additional information was received 28jun2023.The complaint device and another manufacturer¿s sheath were placed inside of a 12french cook sheath at the same time, by puncturing the valve of the 12 french sheath.The sheath hub was used to pull the device from the patient.The dilator was not reinserted into the sheath prior to removal, as the rosen wire and other manufacturer¿s stent were still in the lumen of the sheath.The sheath was removed with a clamp.The patient required unspecified treatment for blood loss.

• 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: 17173207
• Report Number: 1820334-2023-00791
• Device Sequence Number: 7338071
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)251221(10)15136062
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023

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 Expiration Date: 12/21/2025
• Device Model Number: G49045
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL1-HC
• Device Lot Number: 15136062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 09/13/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/14/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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: BD 8X26X80 LIFESTREAM VASCULAR STENT; BD LIFESTREAM VASCULAR STENT; THSCF-35-180-1.5 ROSEN WIRE; UNSPECIFIED .035 TERUMO DEVICE; UNSPECIFIED 12 FRENCH ANSEL SHEATH; UNSPECIFIED 12 FRENCH ANSEL SHEATH; UNSPECIFIED ROSEN WIRE; UNSPECIFIED TERUMO DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 150 KG