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

Model Number	G56235
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = radiology tech.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
As reported, during an unspecified veterinary procedure on an unknown animal species, the hub separated from a flexor high-flex ansel guiding sheath's dilator.Additional information has been requested.
Event or Problem Description
As reported, during an unspecified veterinary procedure on an unknown animal species, the hub separated from a flexor high-flex ansel guiding sheath's dilator.Additional information has been requested.
Additional Manufacturer Narrative
Occupation = radiology tech.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional 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 or Problem Description
Additional information was received 01mar2022.The event occurred in a veterinary training college.The hub separated from the dilator while flushing the device, during preparation on the back table.The intended access site was the right femoral artery for advancement into the aorta, across the patent ductus arteriosus, and into the pulmonary artery; however the device did not make patient contact.Another sheath was used to complete the procedure.There were no adverse effects to the animal.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified veterinary procedure on an unknown animal species, the hub separated from a flexor high-flex ansel guiding sheath's dilator.Additional information was received 01mar2022.The event occurred in a veterinary training college.The hub separated from the dilator while flushing the device, during preparation on the back table.The intended access site was the right femoral artery for advancement into the aorta, across the patent ductus arteriosus, and into the pulmonary artery; however, the device did not make patient contact.Another sheath was used to complete the procedure.There were no adverse effects to the animal.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.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The dilator and hub were separated.A document-based investigation evaluation was performed.The investigation found that the affected component is supplied to cook from an external supplier.Cook requested that the supplier investigate this occurrence.The supplier concluded that the tubing was not loaded into the proper location in the injection mold.Given the supplier investigation conclusion, all dilator subassembly lots and final lots were reviewed for related non-conformances and complaints received from the field.The search revealed no relevant non-conformances on any of the subassembly or final lots.Additionally, there have been no related complaints received on the final lots.Therefore, this manufacturing deficiency, at the supplier level, is believed to be an isolated event.There is no evidence that additional product is affected.The product ifu instructs, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that the device was manufactured out of specification; however, there is no evidence of additional 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 a manufacturing/quality control deficiency contributed to this incident.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 HIGH-FLEX 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 ; 8123392235
• MDR Report Key: 13549624
• Report Number: 1820334-2022-00246
• Device Sequence Number: 5187049
• Product Code: DYB
• UDI-Device Identifier: 00827002562356
• UDI-Public: (01)00827002562356(17)240602(10)14002115
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2022

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: 06/02/2024
• Device Model Number: G56235
• Device Catalogue Number: KCFW-5.0-35-55-RB-HFANL1-HC
• Device Lot Number: 14002115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 05/31/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/07/2022; 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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