MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

Model Number M0062101420

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.Prior to the procedure, a discoloration on the device was noted.A photo submitted by the customer showed the discoloration on the catheter near the balloon.The procedure was completed with another nephromax balloon catheter.There were no patient complications reported as a result of this event.

• Brand Name: NEPHROMAX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11862312
• MDR Text Key: 251967617
• Report Number: 3005099803-2021-02407
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729826491
• UDI-Public: 08714729826491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121614
• 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
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: M0062101420
• Device Catalogue Number: 210-142
• Device Lot Number: 0026413686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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