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

Model Number	M0062101620
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.(b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005099803-2022-07615
• Device Sequence Number: 7426381
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male