MAUDE Adverse Event Report: COOK INC LIVER ACCESS AND BIOPSY SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event occurred sometime in (b)(6) 2019.Relevant tests/lab data: ct imaging.Occupation: risk manager.Pma/510(k) #: preamendment.(b)(4).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
It was reported from hhs/fda 3500a a liver access and biopsy set was used in a (b)(6)-year-old male patient during a transjugular biopsy of the liver procedure.As reported, the patient experienced clinical changes in medical condition (hypotension) the following day.An abdominal ct was performed, upon review of the scan a portion of the catheter (approximately 3in) was found to be in the hepatic vein.According to report, patient underwent an image guided retrieval of the catheter fragment.There is no further information regarding patient outcome.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 28mar2019.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The customer returned a used and damaged fragment of a catheter from the set.This fragment reportedly was retained in the patient and later retrieved.There is dried biological matter on the surface of and within the catheter.One of the ends is undamaged and rounded with a small taper.This end is believed to be the distal end of the catheter.The proximal end of the catheter appears split, torn, and twisted.The outer diameter of the catheter was measured to be within specification.The device cannot be confirmed to be manufactured out of specification.Additionally, a document based investigation evaluation was performed of lot 8833850 showed no related nonconformances.The access needle subassembly lots and catheter subassembly lot were also reviewed.No related nonconformances were found under any of the reviewed subassembly lots.A software search revealed no other complaints under lot 8833850 at the time of investigation.Based on the information provided, a definitive conclusion could not be determined.It is possible that the catheter fragment separated due to hasty withdrawal through the metal stiffening cannula.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Event or Problem Description
Additional information was provided by the customer on 28mar2019.It was reported the patient underwent a cavogram procedure in which the fragment was successfully retrieved from the middle hepatic vein.Per the customer, hypotension did not resolve following removal of the fragment due to other co-morbidities complicating recovery.No additional adverse effects were experienced by the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8448944
• Report Number: 1820334-2019-00732
• Device Sequence Number: 18939827
• Product Code: DYB
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)210423(10)8833850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: N/A
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 8833850
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 05/07/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 03/29/2019; 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 111