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

Model Number	M0062101170
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.Reportedly, the sheath got stuck in the tissue but was eventually taken out without extra bleeding.The procedure was completed a different device.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.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.Reportedly, the sheath got stuck in the tissue but was eventually taken out without extra bleeding.The procedure was completed a different device.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.***additional information received on (b)(6), 2020*** it was reported that the anatomy location was in the kidney.Also, the balloon was noted to burst at under 20 atm.The patient had a minor bleeding as a result of this event; however, the patient was stable at the conclusion of the procedure.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable event of balloon burst.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.Additional information: block b5 (describe event or problem) block e1 (physician's first name and initial reporter address 2) block h6 (patient code).

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10245885
• Report Number: 3005099803-2020-02687
• Device Sequence Number: 10896803
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2022
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0023752593
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1