MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 020015

Device Problems Flaked (1246); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Concomitant products: 22 french cystoscope.(b)(4).Pma/510(k) # preamendment.Investigation ¿ evaluation: the device was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A review of the manufacturing instructions, quality control data and specifications was conducted.A device history record review was unable to be performed as the complaint device lot number was not provided.A review of complaint history records for the complaint device lot number also could not be performed without the associated device lot number.A document review was carried out which identified that the tubing that makes up the portion of the device that is placed in the patient has ink marks but no coating.The coating that is reported as being found in the patient is likely shavings from the exterior of the radiopaque tubing.The lot number was not provided and so a search for additional complaints or manufacturing non-conformances could not be carried out.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.No conclusion could be drawn based on the information available to investigate this customer complaint.

Event Description

It was reported during an extra corporeal shockwave lithotripsy (eswl) procedure the open-end ureteral catheter, g14274 was used.While placing a stent, the surgeon noticed debris in the bladder.The or tech (ort) examined the open-ended catheter and realized there was a line of coating that was missing.A grasper was used to remove most of the material.No harm to patient.As reported during follow up, the product is not available for return and the lot number is not available.No portion of the device remained in the patient¿s body.No additional procedures were required due to this occurrence.As reported, there were no adverse effects on the patient.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7560075
• MDR Text Key: 109760178
• Report Number: 1820334-2018-01539
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 020015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2018
• 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
• Patient Age: 68 YR