MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Respiratory Distress (2045); No Code Available (3191)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Device available for evaluation: unknown.Pma/510(k) #: exempt.(b)(4).This report includes information known at this time.Submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a ultrathane mac-loc locking loop multipurpose drainage catheter for an unknown procedure.After placement, the operator noticed "the drain mismatched at an unplanned location" in the patient's bed.This led to "important respiratory distress to the patient", resulting in the need for an emergency placement of a similar device.The patient was successfully stabilized.No other adverse effects were reported for this incident.Additional information regarding the patient and procedure has been requested but is currently unavailable.

Event Description

No additional patient or event information has been received since the last report was submitted on 30sep2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable d10 ¿ product received on: 04dec2019.Investigation - evaluation: a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One used catheter was returned for investigation.Physical examination of the returned device showed the hub separated from the tubing and biomatter was noted throughout the device.The flare was undamaged, suggesting that the flare was pulled through the hub and cap.No damage was noted to the flare.Dimensions deemed relevant to the reported failure mode were analyzed and determined that the device was manufactured within specification.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record found one non-conformance related to the reported failure mode.The reported product goes through a 100% inspection for the reported nonconformance, and all nonconforming product was scrapped.A review of complaint history records shows no other complaints associated with the complaint device lot.Due to this information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that a manufacturing and quality deficiency contributed to the reported failure mode.Corrective actions including implementation of a gap gauge and retraining were performed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

Manufacturer Narrative

Additional information: b5 - description of event: additional information was provided on 27sep2019.The drainage device "disconnected itself at an unintended point".The patient experienced acute respiratory distress.The device was removed urgently and replaced with a similar device to complete the procedure.The patient became stable after completion of the procedure.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: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9104381
• MDR Text Key: 159614389
• Report Number: 1820334-2019-02384
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)220705(10)9858556
• 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: 12/17/2019

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 Expiration Date: 07/05/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 9858556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 12/13/2019
• Supplement Dates FDA Received: 09/30/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 75