MAUDE Adverse Event Report: COOK INC DRAINAGE SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Initial reporter also sent report to fda: unknown.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 Description

It was a drainage sets reported a was placed by a physician on (b)(6) 2018.The physician reported that the drainage set catheter was found to be separated on (b)(6) 2018.The catheter broke inside the liver, and could not be retrieved.The catheter remains in the liver, as the physician is planning to use an intraperitoneal drainage to drain bile leaking to outside the liver.It was reported, at this time the physician unsure of the plan of care for the patient and removal of the catheter.The physician speculated that the catheter may have broke as a result of motion created by the patient's respiratory variation, but this could not be confirmed.Additional information regarding the event and patient outcome has been requested but is currently unavailable.No other adverse effects were reported for this incident.

Manufacturer Narrative

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.

Event Description

On 30jan2019, it was reported the patient expired.The physician does not think this was attributed to the product, but due to the patient's original condition.Further event details are as follows: it was reported the biliary drain was placed on (b)(6) 2018 to treat advancing cancer of the extrahepatic biliary tract and obstructive jaundice.It was observed on 29dec2019 that the catheter was bent and separated.A separated piece remained in the liver.The fragment was not removed, as the patient developed peritonitis due to the leakage of bile.An abdominal drain was then placed to drain the bile leakage.On (b)(6) 2019, the patient expired.Per the cook representative, ¿.The patient died but the physician thinks the direct cause of the patient's death is advancing cancer.".

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, manufacturing instructions, quality control, documentation, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The visual inspection found the separation occurred on the tubing below the proximal hub.The length of catheter tubing that remained in the patient was confirmed.Black markings and kinking along the tubing that appeared to be from clamping were observed.The separation appeared clean, with no evidence of elongation or pulling.The device was confirmed to be manufactured within specifications.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The technical file associated with these devices indicate the risks are acceptable when weighed against the benefits.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The clinical assessment states that it is likely the patient died due to biliary cancer.Further, the physician associated with this case stated he did not think the failure of the catheter caused the death of the patient, but was caused by the "advancement" of the patient's cancer.Based on the information provided, the examination of returned product, and the results of the investigation, a definitive root cause could not be established.The separation also appeared to be clean and straight, suggesting that it had not been pulled apart by excessive tensile force.It is possible that the device became cut/separated on something during patient movement or during maintenance.Unknown occurrences due to patient anatomy also could have contributed to the failure mode but none of these potential factors could be confirmed.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 Description

Responses to further inquiries about the event were received by the manufacturer on (b)(6) 2019.It was reported the fragment that remained in the patient was 22cm long.This fragment was initially confirmed to remain in the patient through imaging.Additional information received restates or confirms details of the event that have been previously reported.No other additional information regarding the patient and/or event has been received.

• Brand Name: DRAINAGE SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8271127
• MDR Text Key: 133875438
• Report Number: 1820334-2019-00194
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTCD-R2-PIG-HRT-102193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 02/15/2019
• Supplement Dates FDA Received: 02/25/2019; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention