MAUDE Adverse Event Report: COLOPLAST A/S PERCUTANEOUS PUNCTURE NEEDLE; NEPHROSTOMY CATHETER INTRODUCTION NEEDLE

Catalog Number RAC018

Device Problems Accessory Incompatible (1004); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

According to the available information when the other company's guide wire passed through the device the tip of the wire sheared off and is thought to remain in the patient's kidney.

Manufacturer Narrative

No lot number and no sample were available, so no documentary or sample investigation could be made.Furthermore, with additional information received we can define that the guidewire used with chiba needle was a zipwire¿ hydrophilic guidewire from boston scientific.According to the prescriptive information found in boston site these two medical devices were not compatible.On the boston document it was stated: "do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire.Extreme caution should be observed when used with a one-wall puncture style needle." the damage observed on the guide wire was due to the incompatibility of this kind of guide wire with our chiba needle.A similar case study based on the item number rac018, over last four years identified no similar cases.A risk management framework evaluation was performed and concluded that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.A clinical assessment was performed and concluded that the incident of boston sc.Zipwire hydrophilic guidewire rupture at the tip is related to the use through a puncture needle instead of a ureteroscope.Therefore, such incident is considered as not related to the chiba needle.

Event Description

The separated portion was removed along with other stone fragments in a left rigid/flexible ureteroscopy with laser stone treatment, stone basketing, retrograde pyleogram and ureteric stent insertion.

• Brand Name: PERCUTANEOUS PUNCTURE NEEDLE
• Type of Device: NEPHROSTOMY CATHETER INTRODUCTION NEEDLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18056090
• MDR Text Key: 327178005
• Report Number: 9610711-2023-00239
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• 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: 05/30/2024

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 Catalogue Number: RAC018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention