MAUDE Adverse Event Report: COOK INC ULTRATHANE DRAINAGE CATHETER

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: event occurred sometime in (b)(6) 2020.Suspect medical device: unspecified ultrathane drainage catheter.Common device name: unknown as exact device identity is not known.Initial reporter occupation: unknown.Pma/510(k) #: unknown as exact device identity is not known.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 an unknown patient required an unspecified ultrathane drainage catheter for a drainage catheter exchange procedure in (b)(6) 2020.Once the drain was correctly positioned, the flexible stiffener was not easily removable.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) hospital/bmi in the united kingdom informed cook that in (b)(6) 2020, the stiffener in an unknown ultrathane multipurpose drainage catheter from an unknown lot was difficult to remove from the catheter.The failure occurred during a catheter exchange.The patient did not experience adverse effects.A review of the complaint history, instructions for use (ifu), and quality control of the device were conducted during the investigation.The device was not returned for evaluation.This customer reported a similar complaint for this device failure (reported under medwatch report #:1820334-2020-02247).The returned device evaluation for the additional complaint from the facility showed: one used ult8.5 with the blue flexible stiffener lodged in the catheter.The stiffener was removed with difficulty and is elongated on the proximal end.The catheter was cut to obtain measurements.The cause of the event was supplier manufacturing deficiency.Additionally, a document based investigation evaluation was performed.There are appropriate inspections in place to address this failure.The product rpn and lot number is unknown.The customer was unable to provide details regarding the device size or characteristics.Cook is unable to identify the potential lot with the provided information.Based on the device master record review and design history file there is no indication the device was manufactured out of specification.There is no evidence of nonconforming material from this lot in house or in the field.A capa was previously opened for this device failure.The capa implemented corrective actions related to supplier manufacturing.Because the lot number was not provided, it is unknown whether the complaint lot underwent these corrective actions.Based on the information provided, no inspection of returned product and the results of the investigation, it is possible that the cause of this event is supplier manufacturing.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

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

• Brand Name: ULTRATHANE DRAINAGE CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10952548
• MDR Text Key: 220445178
• Report Number: 1820334-2020-02248
• Device Sequence Number: 1
• Product Code: LJE
• 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
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1