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

Model Number G12266

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Customer (person) - postal code: (b)(6), phone: (b)(6).Device evaluated by mfg = other - device evaluation has begun; however, a conclusion is not yet available.This complaint is being reported out of an abundance of caution.There have been no reported adverse effects to the patient and no treatment/intervention was required in this case; however, patient tissue was noted upon return and initial evaluation of the device, which was reportedly used within the brachial artery.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 a right femoral-popliteal angiogram, an unknown thick white substance was noted on a flexor raabe guiding sheath upon removal of the device.The patient's anatomy was tortuous, calcified, and scarred.The patient also had a history of an amputation, severe stenosis of the left femoral and iliac arteries, and severe disease in the right iliac artery at the bifurcation; therefore, brachial access was obtained in the left arm to reach the right iliac artery.Advancement of the sheath over an unspecified 260-centimeter amplatz wire was reportedly smooth until approximately twenty centimeters, at which point the patient screamed in pain and the sheath would no longer advance.The sheath was in place for only a few seconds and was immediately removed when the patient reported pain.After removal, a "thick white layer" was noted on the sheath.Per the reporter, vessel spasms were not noted during the procedure; however, the patient had very small vessel diameters.Heparin, verapamil, and fentanyl were given to try to enlarge the vessel diameters during the procedure.The angiogram was aborted and the patient was sent to surgery for a bypass procedure.It should be noted that the user reported that the "thick white layer" was noted "around hydrophilic coating"; however, the reported complaint device is not manufactured with a hydrophilic coating.Per the reporter, no part of the device remained in the body, no additional procedures were required, and the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, a thick white substance was noted on the sheath, as well as pink/red and yellow tissue consistent with biomatter.

Event Description

No additional information has been received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a right femoral-popliteal angiogram, an unknown thick white substance was noted on a flexor raabe guiding sheath upon removal of the device.The patient's anatomy was tortuous, calcified, and scarred.The patient also had a history of an amputation, severe stenosis of the left femoral and iliac arteries, and severe disease in the right iliac artery at the bifurcation; therefore, brachial access was obtained in the left arm to reach the right iliac artery.Advancement of the sheath over an unspecified 260-centimeter amplatz wire was reportedly smooth until approximately twenty centimeters, at which point the patient screamed in pain and the sheath would no longer advance.The sheath was in place for only a few seconds and was immediately removed when the patient reported pain.After removal, a "thick white layer" was noted on the sheath.Per the reporter, vessel spasms were not noted during the procedure; however, the patient had very small vessel diameters.Heparin, verapamil, and fentanyl were given to try to enlarge the vessel diameters during the procedure.The angiogram was aborted, and the patient was sent to surgery for a bypass procedure.It should be noted that the user reported that the "thick white layer" was noted "around hydrophilic coating"; however, the reported complaint device is not manufactured with a hydrophilic coating.Per the reporter, no part of the device remained in the body, no additional procedures were required, and the patient did not experience any adverse effects due to this occurrence.Upon return and initial evaluation of the device, a thick white substance was noted on the sheath, as well as pink/red and yellow tissue consistent with biomatter.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.A thick white layer of biomatter was noted, starting at 4.5-centimeters from the distal tip.The area of biomatter was 10.7-centimeters in length.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, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider alternate treatment strategy.¿ 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 the patient¿s anatomy contributed to this incident.The anatomy was tortuous, calcified, and scarred.Brachial access was obtained, as the patient also had a history of an amputation, severe stenosis of the left femoral and iliac arteries, and severe disease in the right iliac artery at the bifurcation.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 RAABE 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: 13053653
• MDR Text Key: 288288348
• Report Number: 1820334-2021-02725
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002122666
• UDI-Public: (01)00827002122666(17)240917(10)14219023
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G12266
• Device Catalogue Number: KCFW-6.0-38-90-RB-RAABE
• Device Lot Number: 14219023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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: 5FR MICROPUNCTURE
• Patient Outcome(s): Other
• Patient Sex: Female