MAUDE Adverse Event Report: COOK INC ULTRATHANE GORDON LARGE-BORE CURVED DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Catalog Number ULT22.0-38-40-P-6S-MPA-GLD-HC

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: exempt.(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 reported the inner dilator of a ultrathane gordon large-bore curved drainage catheter cracked at the tapered tip when advancing in patient over the wire.This dilator was removed and another device was used to successfully complete the drainage procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection/dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed one 22.0 french catheter in a used condition.The device was returned with the drainage stiffener fully inserted.There appears to be biomatter on the distal portion of the catheter and stiffening cannula.There are four crude drainage holes beneath the specified five suture holes; it appears that the customer may have modified the device.Upon removal of the stiffener, no resistance was encountered.Biomatter was present on the drainage stiffener.The reported crack was located at the distal tip of the drainage stiffener; the crack runs 1.6cm down shaft starting at the distal tip.There also appears to be a second crack, 8mm in length, also running length-wise down the distal tip.The stiffener taper length measured to be 15mm and the catheter length measured at 40cm.The stiffener outer and inner diameters and the catheter inner and outer diameters were all found to be within manufacturing specifications.The end-hole of the stiffener could not be gathered due to the damage.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The drainage catheter and stiffener are matched through the manufacture and the tip is examined for damage at multiple points.There are no identified gaps in the manufacture and quality controls at this time.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Ifu: ¿warnings ¿ if a catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.¿ ¿how supplied ¿ store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause is product use and handling (possible-product received excessive pressure/actual-product modified after distribution).The appropriate personnel have been notified, and this failure mode will continue to be trended.Per the quality engineering risk assessment, no further action is required.

Event Description

No new event description information to report at this time.

• Brand Name: ULTRATHANE GORDON LARGE-BORE CURVED DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7450061
• MDR Text Key: 106632949
• Report Number: 1820334-2018-01017
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002125124
• UDI-Public: (01)00827002125124(17)200320(10)7763009
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULT22.0-38-40-P-6S-MPA-GLD-HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1