MAUDE Adverse Event Report: COOK INC ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Occupation: member support analyst.Initial reporter also sent report to fda: unknown.Pma/510(k) #: exempt.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, an unknown patient required the placement of an ultrathane intro-tip design curved universal drainage catheter for an unknown drainage procedure.The operator reported the "drainage catheter came loose from the connector." this occurred with two devices.Additional information has been requested for this event, but is currently unknown.No adverse effects were reported.

Event Description

Additional information was received on 02dec2020.The patient required the device for a chest tube placement.After placement, the device separated.On the following day, the device was removed and a second device of the same lot was placed.This caused the patient to be hospitalized an extra day.However, the second device separated during the procedure.The device was removed and a third device was used to successfully complete the procedure.The second device is captured under medwatch report#: 1820334-2020-02319.

Manufacturer Narrative

H6 ¿ patient code: 3191 [no code available]- additional procedure required to replace device.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation - evaluation: (b)(6) health system (united states) informed cook on 13nov2020 that the hub on a ult10.2-38-25-p-3s-ucd-hc (ultrathane intro-tip design curved universal drainage catheter) from lot 13006135 separated after placement.The device had been successfully placed as a chest tube, and the failure was noticed after it was placed.The device was removed and another device from the same lot was placed in a separate procedure.The second device separated during the procedure and is captured under mdr ref.# 1820334-2020-02319.A third device was placed to successfully complete the procedure.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and dimensional verification of the returned device, was conducted during the investigation.One ult catheter tube without the hub was returned to cook for evaluation.Upon visual inspection, it was noted that the catheter had previously been cut below the flare.A hemostat mark was noted below the flare.The catheter tubing outer diameter was measured and found to within manufacturing tolerance.Cook has concluded that the device was manufactured to specification.Additionally, 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.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr for the reported complaint device lot 13006135 revealed no related non-conformances.A database search identified one additional event associated with the reported device lot.The additional identified event was reported by the same customer for a separation failure mode.Given this information, cook has concluded that there is no evidence suggesting that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device is supplied with instructions for use [ifu t_multi_rev5], which provides the following in relation to the reported failure mode: ¿patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.¿ based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause for this event has been traced to component failure unrelated to a deficiency in manufacturing/device design.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.

• Brand Name: ULTRATHANE INTRO-TIP DESIGN CURVED UNIVERSAL 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: 10908952
• MDR Text Key: 218672496
• Report Number: 1820334-2020-02184
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002109599
• UDI-Public: (01)00827002109599(17)230224(10)13006135
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2021

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: 02/24/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-3S-UCD-HC
• Device Lot Number: 13006135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 02/19/2021; 03/15/2021
• Supplement Dates FDA Received: 12/16/2020; 03/03/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention