MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET; DYB INTRODUCER, CATHETER

Model Number G02972

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: clinical specialist.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 preparation for an unknown procedure, a micropuncture transitionless pedal access set was found to be missing from the outer package due to an incomplete or missing seal.No patient harm has been reported.

Manufacturer Narrative

Event summary: as reported, during preparation for an unknown procedure, a micropuncture transitionless pedal access set was found to be missing from the outer package due to an incomplete or missing seal.No patient harm has been reported.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints on the product lot or on lots packaged and sealed by the same operator.There is no evidence of any additional nonconforming devices from the complaint lot in house or in the field.The device is provided with instructions for use which state, ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that a manufacturing deficiency contributed to this incident.There is no evidence that additional product was affected or that non-conforming product from this lot exists in house or in the field.The responsible personnel was retrained to prevent this failure from recurring.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11886771
• MDR Text Key: 266476592
• Report Number: 1820334-2021-01405
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)240217(10)13764754
• Combination Product (y/n): N
• PMA/PMN Number: K172980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/17/2024
• Device Model Number: G02972
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Device Lot Number: 13764754
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1