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

Model Number G56220

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2022

Event Type  Injury  

Event Description

As reported, during an unspecified procedure, a flexor high-flex ansel guiding sheath separated.Another manufacturer's balloon was used through the sheath.When the user attempted to remove the sheath and balloon, the balloon became stuck in the sheath.The user then attempted to remove the sheath to exchange it, at which point the sheath separated.The separated portion of the sheath and balloon were successfully retrieved from the patient.The patient is reportedly fine.Additional information has been requested.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.

Manufacturer Narrative

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

Manufacturer Narrative

Event summary: as reported, during an unspecified procedure, a flexor high-flex ansel guiding sheath separated.Another manufacturer's balloon was used through the sheath.When the user attempted to remove the sheath and balloon, the balloon became stuck in the sheath.The user then attempted to remove the sheath to exchange it, at which point the sheath separated.The separated portion of the sheath and balloon were successfully retrieved from the patient.The patient is reportedly fine.The procedure was a peripheral endovascular intervention.Access was obtained in the common femoral artery, which was also the reported target location.The other manufacturer¿s balloon had been used prior to the event.An unknown wire was in the lumen of the sheath at the time of separation.Resistance was reported upon attempted sheath removal.The separated portion of the sheath and balloon were successfully retrieved from the patient by inserting a larger sheath and balloon and using the larger balloon to pull the separated sheath into the larger sheath.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.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, device history record (dhr), quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.In response to this incident, cook reviewed the dhr.The dhr for the reported device lot records one relevant nonconformance; the lone affected device was scrapped, and there are 100% inspections to capture this nonconformance.A database search for complaints on the reported lot found no additional complaints reported from the field.As adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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.When inserting, manipulating, or withdrawing a device through the sheath, always maintain sheath position.¿ instructions for use: ¿sheath introduction: 1.Ensure that the inner diameter (id) of the sheath is appropriate for the maximum diameter of the instruments to be introduced.¿ based on the available information and a clinical assessment of the event, cook has concluded that a cause for this event could not be identified at this time.A capa investigation is currently open to further investigate this failure mode.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 Description

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

Event Description

Additional information was received.The procedure was a peripheral endovascular intervention.Access was obtained in the common femoral artery, which was also the reported target location.The other manufacturer¿s balloon had been used prior to the event.An unknown wire was in the lumen of the sheath at the time of separation.Resistance was reported upon attempted sheath removal.The separated portion of the sheath and balloon were successfully retrieved from the patient by inserting a larger sheath and balloon and using the larger balloon to pull the separated sheath into the larger sheath.

Manufacturer Narrative

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.

• Brand Name: FLEXOR HIGH-FLEX 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 ; 8128294891
• MDR Report Key: 14162069
• MDR Text Key: 289678396
• Report Number: 1820334-2022-00620
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002562202
• UDI-Public: (01)00827002562202(17)250120(10)14486772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G56220
• Device Catalogue Number: KCFW-5.0-35-70-RB-HFANL0-HC
• Device Lot Number: 14486772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: BOSTON SCIENTIFIC BALLOON.
• Patient Outcome(s): Required Intervention