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

Model Number G48193

Device Problem Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Initial reporter name and address: customer name and address= (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 Description

As reported, upon completion of an endovascular procedure involving the superficial femoral artery, a flexor shuttle tibial guiding sheath unraveled and separated upon removal of the device from the patient.Minimal resistance was encountered prior to the device unraveling/separating in the middle of the sheath.An incision was made, and an open surgical approach was used to remove the device from the patient.No additional complications were reported.Photos provided by the customer show that an unknown wire was in the sheath lumen.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, b7, d10.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

Additional information was received 20sep2022.Transfemoral access was obtained via the right groin to target a lesion in the left superficial femoral and popliteal arteries.Another manufacturer's wire and balloon were placed through the sheath during the procedure.Both iliac arteries were very tortuous and very calcified.The sheath was in place for approximately one hour.No additional medications or blood products were administered.The sheath was removed successfully in surgery and there have been no adverse effects to the patient.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, upon completion of an endovascular procedure involving the superficial femoral artery, a flexor shuttle tibial guiding sheath unraveled and separated upon removal of the device from the patient.Transfemoral access was obtained via the right groin to target a lesion in the left superficial femoral and popliteal arteries.Another manufacturer's wire and balloon were placed through the sheath during the procedure.Both iliac arteries were very tortuous and very calcified.Minimal resistance was encountered prior to the device unraveling/separating in the middle of the sheath.The sheath was in place for approximately one hour.An incision was made, and an open surgical approach was used to remove the device from the patient.No additional complications were reported.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Photos provided by the user show the flexor sheath separated, connected only by unraveled inner coils.Only an unknown wire guide was seen inserted into the sheath.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which state that 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 states 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.Based on the available information, cook has concluded that patient anatomy and an unintended user error were the cause of the device failure in this incident.As the complaint device was withdrawn, it likely became caught on the patient¿s calcified and tortuous anatomy.Photos of the device also indicate that the dilator was not in the sheath at the time of the separation.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a risk assessment review, no further action is required.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.

• Brand Name: FLEXOR SHUTTLE TIBIAL 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: 15445765
• MDR Text Key: 300136649
• Report Number: 1820334-2022-01500
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002481930
• UDI-Public: (01)00827002481930(17)240728(10)14116682
• Combination Product (y/n): N
• PMA/PMN Number: K142819
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G48193
• Device Catalogue Number: KSAW-4.0-18/35-110-RB-SHTL-HC
• Device Lot Number: 14116682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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: 0.018 TERUMO ADVANTAGE WIRE; 3 MM PACIFIC BALLOON.
• Patient Outcome(s): Required Intervention