MAUDE Adverse Event Report: COOK INC UNKNOWN; Catheter, percutaneous

Catalog Number UNKNOWN

Device Problems Break (1069); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that an unknown cook device "broke".The device was described to be an "art line", and is currently presumed to be an arterial pressure monitoring set.Additional information regarding clarification of the failure mode, as well as patient, device, and event details, has been requested but is currently unavailable.

Manufacturer Narrative

Correction: h6- annex a.Investigation ¿ evaluation.(b)(6) center (united states) contacted cook stating that they had a broken art line.The customer did not provide any patient outcome or procedure details to aid in the investigation.The customer did not provide details regarding the rpn or component of the complaint device.Cook became aware of this event on 21sep2021.This investigation will proceed based on the assumption that "broken art line" means that the catheter component of the pressure monitoring set fractured.Reviews of documentation including the quality control and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned, and no photographs were provided to aid in the investigation; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number to aid in the investigation.A sales report was performed however cook was not able to ascertain a lot number to review the device history record.Cook was not able to determine non-conforming material in house or in the field.A review of capas, fars, pens, and scars was performed.Far-2021-017 was submitted for various pms catheters for failure of tensile strength testing.It is possible that this far is related to this failure.There are no capas, or pens opened or closed related to this failure.Cook was not able to properly review scars due to the lack of a lot number to get a work order.Based on the available information, cook was not able to find evidence the device was manufactured out of specification and cook was not able to find evidence of non-conforming material in house or in field.The customer did not provide a specific rpn for this complaint.A look at the possible rpn¿s for this customer, there are two that have and instructions for use (ifu) pamphlet and the rest do not have an ifu.Ifu c_t_ulmbh_rev7 for pmsy kits states in the how supplied section: upon removal from package, inspect the product to ensure no damage has occurred.Ifu c_t_ulmbhce_rev8 for pms 250 series kits in the how supplied section: upon removal from package, inspect product to ensure no damage has occurred.Based on the available information, no device return, and the results of the investigation, cook was not able to determine a cause for this failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: UNKNOWN
• Type of Device: Catheter, percutaneous
• 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: 12572534
• MDR Text Key: 276694175
• Report Number: 1820334-2021-02282
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1