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

Model Number M0062101620

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that a nephromax balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure on (b)(6) 2022.During the procedure, the renal sheath was advanced and it was noticed that the radiopaque marker was damaged and bent.Under examination, the radiopaque marker fell off the sheath and was removed.Reportedly, some bleeding occurred during deflation of the balloon; however, the procedure was completed at this time.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a nephromax balloon was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure on december 1, 2022.During the procedure, the renal sheath was advanced and it was noticed that the radiopaque marker was damaged and bent.Under examination, the radiopaque marker fell off the sheath and was removed.Reportedly, some bleeding occurred during deflation of the balloon; however, the procedure was completed at this time.There were no patient complications reported as a result of this event.Additional information received on december 19, 2022 that the balloon was not ruptured and damaged.The bleeding was controlled by the physician's expertise and the patient was doing well.Reportedly, the physician could not use fluro when advancing so advancement of the sheath was done under direct visualization.The customer stated that no pieces of the balloon detached inside the patient.

Manufacturer Narrative

H4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: b5 (describe event or problem) block h6: device code a0501 captures the reportable event of radiopaque marker detached in the sheath.

• 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 CORPORATION; ballybrit business park; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16013444
• MDR Text Key: 307767913
• Report Number: 3005099803-2022-07615
• Device Sequence Number: 1
• Product Code: LJE
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

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 Model Number: M0062101620
• Device Catalogue Number: 210-162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male