MAUDE Adverse Event Report: COOK INC ULTRATHANE LUER LOCK COOK-COPE TYPE LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: clinical resource coordinator.Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of an ultrathane luer lock cook-cope type loop biliary drainage catheter for a catheter exchange.It was reported the "hub came off in the physician's hands." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

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

Manufacturer Narrative

Concomitant medical product returned 08jan2020.Investigation - evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complainant returned one catheter for investigation.Physical examination of the returned device showed: the hub was returned detached.Biomatter was present on the distal end of the catheter, and the flare appeared flat and uneven on one side.Thread marks were also noted on one side of the flare.All dimensions deemed relevant to the failure mode were measured and confirmed that the device was manufactured within specification.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A reviewed product labeling was conducted.The product instructions for use (ifu) does not include relevant information for the reported failure mode.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots revealed one non-conformance relevant to the reported failure.All nonconforming products were scrapped, and the product goes through a 100% inspection for the reported nonconformance.A database search for complaints on the reported lot found no additional complaints reported from the field.Due to this information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.It is possible that excessive tension on the hub or an inadequate flare position/size could have caused the separation, but due to the returned condition of the device, this cannot be confirmed.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.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 LUER LOCK COOK-COPE TYPE LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9273495
• MDR Text Key: 165208760
• Report Number: 1820334-2019-02767
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002098299
• UDI-Public: (01)00827002098299(17)220905(10)9993070
• 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
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT18.0-38-40-P-32S-LBCL-HC
• Device Lot Number: 9993070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1