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

Catalog Number KCFW-6.0-18/38-45-RB-ANL2-HC

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

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.

Event Description

As reported, during an "angio" of the right lower extremity, an unspecified cook ansel sheath became stuck, subsequently unraveling and separating upon removal.The dilator was reportedly in place at the time of the event.There were no complications after the procedure.Additional information has been requested.

Event Description

Additional information was received 02aug2022.The patient had a history of a right femoral-to-popliteal bypass graft.Access was obtained in the left common femoral artery during the outpatient procedure, and the device was advanced to the right common femoral artery.Resistance was not encountered upon initial insertion of the sheath.Other manufacturer's angioplasty balloons were used through the sheath during the procedure.Significant resistance was encountered upon removal of the device, during which the dilator and a 0.035-inch wire were in the lumen of the sheath.The shaft unraveled and separated; however, the device did not completely "come apart".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 reporter, the patient did not experience any adverse effects due to this occurrence.The patient was not hospitalized.

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.

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.Event summary.As reported, during an "angio" of the right lower extremity, an unspecified cook ansel sheath became stuck, subsequently unraveling and separating upon removal.The dilator was reportedly in place at the time of the event.There were no complications after the procedure.The patient had a history of a right femoral-to-popliteal bypass graft.Access was obtained in the left common femoral artery during the outpatient procedure, and the device was advanced to the right common femoral artery.Resistance was not encountered upon initial insertion of the sheath.Other manufacturer's angioplasty balloons were used through the sheath during the procedure.Significant resistance was encountered upon removal of the device, during which the dilator and a 0.035-inch wire were in the lumen of the sheath.The shaft unraveled and separated; however, the device did not completely "come apart".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 reporter, the patient did not experience any adverse effects due to this occurrence.The patient was not hospitalized.Investigation - evaluation.Reviews of the complaint history, drawing, instructions for use, and quality control procedures conducted during the investigation.The device was not returned for investigation.Photos provided by the user show the sheath outer and inner layer separated, and coiling is unraveled between the pieces of the sheath.The customer did not provide the lot number for the complaint devices.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record and complaint history could not be reviewed.There is no evidence of nonconforming material 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 warn, ¿if resistance is encountered during advancement of flexor sheath, 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.Reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ based on the available information, cook has concluded a cause could not currently be established for this failure.A capa has been previously opened to further investigate this failure mode and remains ongoing.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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.

• 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: 14704997
• MDR Text Key: 301373794
• Report Number: 1820334-2022-01070
• Device Sequence Number: 1
• Product Code: DYB
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL2-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 08/02/2022; 09/06/2022
• Supplement Dates FDA Received: 08/08/2022; 09/15/2022
• 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: 0.035 AMPLATZ GUIDEWIRE.; 4MM X 40MM ULTRAVERSE ANGIOPLASTY BALLOON.; 6MM X 40MM ANGIOPLASTY BALLOON.
• Patient Sex: Female