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

Model Number	M0062101400
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2020
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 device was used in the right kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2020.It was reported that during preparation, the balloon exploded.The procedure was completed with another nephromax dilatation balloon catheter device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2: additional information: block b5 (describe event or problem).Block h6: device code a0402, captures the reportable issue of balloon burst.Block h10: although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 device was used in the right kidney, during a retrograde intrarenal surgery (rirs) procedure.Performed on (b)(6) 2020.It was reported, that during preparation, the balloon exploded.The procedure was completed with another nephromax dilatation balloon catheter device.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2021.It was reported, that the balloon exploded in the patient's body.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11748215
• Report Number: 3005099803-2021-01983
• Device Sequence Number: 3856360
• Product Code: LJE
• UDI-Device Identifier: 08714729826484
• UDI-Public: 08714729826484
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 0025032040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR