MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY (NEEDLE)

Model Number RJA2101002

Device Problem Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/30/2022

Event Type  Injury  

Event Description

According to the available information, during a percutaneous nephrostomy (pnc) in emergency, the guidewire was damaged during use of the puncture needle.It was noted to be a phenomenon, despite use of different types of guides.As a result, the external layer of a terumo guidewire was detached in the patient's renal cavities (observed on a postoperative scanner, performed in the context of a septic resuscitation emergency).The surgeons think the puncture needle was the cause of the issue.

Manufacturer Narrative

The product in involved in the event was a percutaneous nephrostomy set with j catheter in vortek with stylet, needles, dilator with sheath, and seldinger guidewire.While this kit is not on the us market, coloplast has percutaneous nephrostomy needles on the us market.Common device name and product code correlate to needles, unique identifier, item number, lot number & catalog number are associated with the kit.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

• Brand Name: UNKNOWN
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY (NEEDLE)
• 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: 15241673
• MDR Text Key: 298069596
• Report Number: 9610711-2022-00059
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2022

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: RJA2101002
• Device Catalogue Number: RJA210
• Device Lot Number: 7994659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2021
• 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