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

Model Number M0062101170

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was being used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon popped at 20 atm when inflated inside the patient.The procedure was completed with another nephromax dilatation balloon catheter.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2: additional information: block b5 (describe event or problem), block d7 (sud reprocessed and reused) and block h8 (usage of device) block h6: device code a0402 captures the reportable event of balloon burst.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was being used during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2021.During the procedure, the balloon popped at 20 atm when inflated inside the patient.The procedure was completed with another nephromax dilatation balloon catheter.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2021*** the device was used in the kidney.

• Brand Name: NEPHROMAX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12544524
• MDR Text Key: 273772677
• Report Number: 3005099803-2021-05104
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (y/n): N
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 03/28/2024
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0027052364
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1