MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN; VORTEK J CATHETER WITH STYLET

Model Number RCJ1081002

Device Problem Product Quality Problem (1506)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device required extra time to remove due to a detached connector.The white luer-lock detached from the mandrel.The mandrel did not slide in the device and the surgeon had to remove it in one block.The anesthesia was extended an additional hour.No other adverse patient effects were reported.

Manufacturer Narrative

The sample was received on 16 january 2023.Visually we saw that the whiter luer is dismantled of the metallic mandrel.This issue was known and a awareness with operators was done on (b)(6) 2022 about this topic.Furthermore an update of the production monitoring sheet concerning the gluing step was implanted.The clinical assesment /as mentioned in our ifu, j or malecot percutaneous nephrostomy catheters must only be used by trained and experienced professionals.The examination of incriminated devices and the investigation concluded that a root cause for the incident was a device defect.The incident ¿luer lock unstuck¿ from the stylet tube during bilateral j percutaneous nephrostomy catheter placement (in both kidneys) is known issue (nc tw779229 "rjc108/208) related to product defect (white luer is not gluing correctly).We estimate that ¿luer lock unstuck¿ from the stylet tube, with risks of kidney perforation, bleeding, infection, significant prolonged procedure, represents a clinical risk rated severity parameter level 4 referring to our clinical risk management procedure (b)(4).The rmf is risk identification extract criq209 risk no (b)(4).

• Brand Name: UNKNOWN
• Type of Device: VORTEK J CATHETER WITH STYLET
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16275779
• MDR Text Key: 308839454
• Report Number: 9610711-2023-00005
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K211911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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 Model Number: RCJ1081002
• Device Catalogue Number: RCJ108
• Device Lot Number: 8886615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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 Outcome(s): Required Intervention