MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	G09843
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k171999.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 inferior vena cava (ivc) filter retrieval procedure, the silicone disc valve in the check-flo assembly on a performer introducer dislodged.This was noticed upon opening the packaging of the device.A new device was used to complete 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 this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during an inferior vena cava (ivc) filter retrieval procedure, the silicone disc valve in the check-flo assembly on a performer introducer dislodged.This was noticed upon opening the packaging of the device.A new device was used to complete 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 this occurrence.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, drawing, specifications, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One performer introducer set was returned for investigation.Physical examination of the returned sheath and dilator revealed that there was a kink in the sheath body at 35.5 cm from the hub.The dilator was severely bent, and the end of the sheath the opening was slightly non-circular.The silicone disc was dislodged and in the hub.Biomatter was present on the device.Cook requested that the supplier of the silicone disc and sidearm investigate this incident.The supplier reviewed each lot that had components that were used in the complaint device.The supplier found evidence that possibly a nonconforming unit was improperly segregated, leading the device being shipped to cook with the other conforming components.The supplier concluded that the device was likely manufactured out of specification.A document-based investigation evaluation was also performed by cook.One relevant nonconformance was recorded; both affected devices were scrapped, and the device is inspected 100%.The reported hub assembly raw material lots were used in a total of 72 final lots, none of which had any additional complaints reported from the field.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which state, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that manufacturing and quality control deficiencies were the cause of the device failure.Defect awareness notifications were completed by all responsible personnel.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, 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: PERFORMER INTRODUCER
• 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: 14310806
• Report Number: 1820334-2022-00691
• Device Sequence Number: 12083937
• Product Code: DYB
• UDI-Device Identifier: 00827002098435
• UDI-Public: (01)00827002098435(17)240823(10)NS14166897
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 08/23/2024
• Device Model Number: G09843
• Device Catalogue Number: RCFW-14.0-38-80-RB
• Device Lot Number: NS14166897
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 Age: 64 YR
• Patient Sex: Female