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

Model Number G44154

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an angioplasty procedure, a flexor ansel guiding sheath separated in the left common and external iliac arteries upon withdrawal of the device.General anesthesia was administered and a left femoral approach was used to remove the foreign body.Additional information has been requested.

Event Description

Additional information was received 13aug2022.Access was obtained in the right femoral artery and a contralateral approach was used to advance the sheath to the left external iliac artery.The anatomy was not tortuous or scarred, however, it was reportedly calcified.Stenosis was not noted in the common iliac artery.Unspecified balloons and stents were used during the procedure.Resistance was encountered upon withdrawal of the sheath, which reportedly became stuck at the angle of the aortic bifurcation.The middle of the sheath then separated into two pieces.The dilator was not in place when the separation occurred, and no other devices were in the lumen of the sheath at the time of separation.General anesthesia was administered, and a left femoral approach was used to successfully remove the separated fragment.Reportedly, there have been no adverse effects to the patient.

Manufacturer Narrative

Summary of event: as reported, during an angioplasty procedure, a flexor ansel guiding sheath separated in the left common and external iliac arteries upon withdrawal of the device.Access was obtained in the right femoral artery and a contralateral approach was used to advance the sheath to the left external iliac artery.The anatomy was not tortuous or scarred, however, it was reportedly calcified.Stenosis was not noted in the common iliac artery.Unspecified balloons and stents were used during the procedure.Resistance was encountered upon withdrawal of the sheath, which reportedly became stuck at the angle of the aortic bifurcation.The middle of the sheath then separated into two pieces.The dilator was not in place when the separation occurred, and no other devices were in the lumen of the sheath at the time of separation.General anesthesia was administered, and a left femoral approach was used to successfully remove the separated fragment.Reportedly, there have been no adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.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 anticipated or encountered during withdrawal of the flexor sheath, consider carefully reinserting the dilator to continuing removal.¿ the information provided upon review of customer testimony, the dmr, dhr, and ifu 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 although it is possible that the patient¿s calcified anatomy and/or failure to reinsert the dilator upon encountering resistance may have contributed to this event, a definitive cause for the event cannot be established at this time.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa investigation open to investigate this product failure mode.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9, h3, h6 (annexb), h10.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures and a visual inspection of the device were conducted during the investigation.Examination of the complaint device noted that the sheath was separated into two sections.The inner coil was exposed and stretched at the point of separation.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 anticipated or encountered during withdrawal of the flexor sheath, consider carefully reinserting the dilator to continuing removal.¿ the information provided upon review of customer testimony, the dmr, dhr, and ifu 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 although it is possible that the patient¿s calcified anatomy and/or failure to reinsert the dilator upon encountering resistance may have contributed to this event, a definitive cause for the event cannot be established at this time.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa investigation open to investigate this product failure mode.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
• Type of Device: 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: 14593658
• MDR Text Key: 293276671
• Report Number: 1820334-2022-00997
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)250215(10)14536860
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

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
• Device Operator: Health Professional
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14536860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 08/13/2022; 09/20/2022
• Supplement Dates FDA Received: 08/29/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention