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

Model Number	G44154
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a flexor ansel guiding sheath separated during an unspecified procedure.Additional event and patient outcome information has been requested.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was received 25may2022.The procedure was a "runoff up and over" and mild calcification was reported.Resistance was noted during removal of the device; however, the dilator was not in place during removal of the sheath.An unspecified wire guide was in place upon removal/separation of the device.An unknown manufacturer's balloon was used during the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
H3 - the complaint device was not returned.Event summary as reported, a flexor ansel guiding sheath separated during a "runoff up and over" and mild calcification was reported.Resistance was noted during removal of the device; however, the dilator was not in place during removal of the sheath.An unspecified wire guide was in place upon removal/separation of the device.An unknown manufacturer's balloon was used during the procedure.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to the occurrence.The patient did not experience any adverse effects due to the occurrence.Investigation ¿ evaluation a document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, manufacturing instructions, and quality control data.The complainant did not return the complaint device to cook for investigation and a search of current inventory revealed that no devices from this lot number are available for evaluation from within cook¿s inventory.In response to this incident, cook completed a review of the dhr.The dhr for the related device lot number and sub-assembly lot number had no non-conformances.A database search for complaints on reported lot found no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿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.¿ sheath removal:: ¿remove the sheath.Avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ there is a capa currently open to investigate this complaint failure mode and there is no evidence that the device was manufactured out of specification.Therefore, cook is currently unable to establish a cause for this failure.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.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: 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: 14044412
• Report Number: 1820334-2022-00542
• Device Sequence Number: 14646368
• Product Code: DYB
• UDI-Device Identifier: 00827002441545
• UDI-Public: (01)00827002441545(17)240104(10)13664400
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2024
• Device Model Number: G44154
• Device Catalogue Number: KCFW-6.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13664400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/14/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/06/2022; 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown