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

Model Number G44155

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/06/2022

Event Type  Injury  

Event Description

As reported, in the middle of a procedure involving the left superficial femoral artery via contralateral access in the right common femoral artery, a flexor ansel guiding sheath separated in the patient.The sheath was advanced up and over the bifurcation, over an unspecified amplatz wire, to the left common femoral artery.The anatomy was reportedly very calcified.Another manufacturer's balloon catheter was advanced through the sheath, over an unknown 0.014-inch wire, and was then inflated within a calcified lesion in the left superficial femoral artery.The balloon would not completely deflate, and the distal four-to-five centimeters of the balloon remained inflated and stuck in calcified lesion.The balloon was eventually popped with an external needle; however, the balloon was still unable to be removed through the sheath.After multiple attempts to remove the balloon, the balloon catheter shaft separated, leaving the tip of the balloon catheter in the patient.While trying to snare the separated balloon catheter and remove the sheath with the balloon catheter inside, resistance was encountered and the tip of the complaint device then separated, leaving the distal portion of the sheath in the patient.The dilator was not in place when the separation occurred.The patient was sent to surgery for retrieval of the separated sheath and other manufacturer's balloon catheter.The patient is reportedly "ok"; however, did require hospitalization.

Manufacturer Narrative

It is unknown if the device will be returned.Occupation = inventory manager.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 Description

A medwatch report was received 27sep2022 and additional information was received from the customer on 29sep2022.The patient had bilateral pre-existing stents (not kissing) in the common iliac arteries.The bifurcation angle was normal; however, the bifurcation was moderately calcified.Another manufacturer's 0.014-inch balloon was in the lumen of the sheath at the time of separation, over an unknown 0.014-inch wire.An unknown balloon was used to "pin and pull" the remaining portion of the other manufacturer's separated balloon material from the patient, when the sheath fractured.After the sheath separated, an amplatz wire was placed down the leg and the patient was transferred to surgery.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a3, a4, a5a, a5b, b5, b6, b7, d8, e4.Medwatch 1497797086-2022-0008 was received 27sep2022.Per the medwatch, the device is available for evaluation; however, the device has not yet been received and the customer has not confirmed that the device will be returned to cook.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 Description

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

Manufacturer Narrative

Summary of event: as reported, in the middle of a procedure involving the left superficial femoral artery via contralateral access in the right common femoral artery, a flexor ansel guiding sheath separated in the patient.The sheath was advanced up and over the bifurcation, over an unspecified amplatz wire, to the left common femoral artery.The anatomy was reportedly very calcified.Another manufacturer's balloon catheter was advanced through the sheath, over an unknown 0.014-inch wire, and was then inflated within a calcified lesion in the left superficial femoral artery.The balloon would not completely deflate, and the distal four-to-five centimeters of the balloon remained inflated and stuck in calcified lesion.The balloon was eventually popped with an external needle; however, the balloon was still unable to be removed through the sheath.After multiple attempts to remove the balloon, the balloon catheter shaft separated, leaving the tip of the balloon catheter in the patient.While trying to snare the separated balloon catheter and remove the sheath with the balloon catheter inside, resistance was encountered and the tip of the complaint device then separated, leaving the distal portion of the sheath in the patient.The dilator was not in place when the separation occurred.The patient was sent to surgery for retrieval of the separated sheath and other manufacturer's balloon catheter.The patient is reportedly "ok"; however, did require hospitalization.A medwatch report was received 27sep2022 and additional information was received from the customer on 29sep2022.The patient had bilateral pre-existing stents (not kissing) in the common iliac arteries.The bifurcation angle was normal; however, the bifurcation was moderately calcified.Another manufacturer's 0.014-inch balloon was in the lumen of the sheath at the time of separation, over an unknown 0.014-inch wire.An unknown balloon was used to "pin and pull" the remaining portion of the other manufacturer's separated balloon material from the patient when the sheath fractured.After the sheath separated, an amplatz wire was placed down the leg and the patient was transferred to surgery.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation; however, photos provided by the customer show that the sheath separated.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 that reinsertion of the dilator prior to removal of the sheath ¿increases the strength of the sheath and lessens the risk of device separation¿ and suggests insertion of the dilator prior to removal if resistance is encountered or anticipated during withdrawal of the device.The ifu also cautions ¿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.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of photos 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 anatomy contributed to this event, as the separation occurred during attempts to remove a balloon that was stuck within the calcified anatomy.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.

• 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: 15475015
• MDR Text Key: 300555025
• Report Number: 1820334-2022-01519
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)240625(10)14052094
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G44155
• Device Catalogue Number: KCFW-7.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 14052094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: NANOCROSS ELITE AB14W040150150 LOT B264915
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American