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

Model Number M0062101620

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

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of two nephromax balloon catheter kits used in the same patient and procedure.It was reported to boston scientific corporation that two nephromax balloon catheter kits were used during a procedure performed on an unknown date.It was reported that while unpacking of the device during preparation, it was noticed that both devices look dark and dirty.A photo submitted by the customer confirmed the foreign material present on the device.The procedure was completed with another nephromax balloon catheter kit.No patient complications have been reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: NEPHROMAX KIT
• 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: 11463603
• MDR Text Key: 239176268
• Report Number: 3005099803-2021-01039
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2021

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: 06/17/2022
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Device Lot Number: 0024600052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1