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

Model Number M0062101400

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Weight: (b)(6) kg.(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

Note: this report pertains to three nephromax dilatation balloon catheters that were used in the same patient and procedure.It was reported to boston scientific corporation that three nephromax dilatation balloon catheters were used in the right kidney during a right percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, it was noted that the balloons ruptured.The procedure was completed with another nephromax dilatation 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: 10596748
• MDR Text Key: 208855894
• Report Number: 3005099803-2020-04262
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729826484
• UDI-Public: 08714729826484
• 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: 09/28/2020

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: 10/28/2022
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 0024675873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• 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 Age: 48 YR