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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Occupation: (b)(6).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, before an unknown procedure the user was attempting to thread the wire when the tip separated and split.The device did not make patient contact.It is unknown how the procedure was completed.

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, unchanged, or unavailable.Corrected information= the following information was available and inadvertently omitted from the initial mdr: b3: the event occurred approximately two weeks prior to the date aware.D1: the device was an unspecified hi-flex ansel sheath.Summary of event: as reported, before an unknown procedure, the user was attempting to thread the wire when the tip separated and split.The device did not make patient contact.It is unknown how the procedure was completed.Investigation evaluation: reviews of the complaint history, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Due to this, no dimensional, visual, or functional testing could be completed.Reviews of the device drawings, specifications, and quality control procedures were reviewed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number for investigation.Due to this, cook could not complete a review of the device history record (dhr) or a database search for additional complaints from the field.However, based on the ¿hi-flex ansel¿ descriptor, cook is suspecting that the affected rpn falls under the scope of a previously submitted recall.Two customer letters have been sent to this reporting customer, and a signed acknowledgment form has not been received from this customer.Cook is continuing to follow-up with non-responding customers.The device's design history files (dhf) were reviewed, and the current risk controls, which include verification through quality control, are adequate.The product ifu states ¿upon removal form package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the results of the investigation, cook could not conclude a cause of failure at this time.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa and scar investigation open to investigate this product failure.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: UNKNOWN
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11031898
• MDR Text Key: 223800112
• Report Number: 1820334-2020-02334
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1