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

Model Number	M0062101170
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.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
Note: this report pertains to one of two nephromax dilatation catheter used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax dilatation catheter was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst under 20 atm which caused a lot of bleeding to the patient.Reportedly, the patient stayed at the hospital for one week before being discharged.The same issue occurred with the second nephromax dilatation catheter.The percutaneous nephrolithotomy procedure was cancelled.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: a visual examination of the returned complaint device confirmed that the balloon was unfolded and had been subjected to positive pressure.A longitudinal tear was also noted at the balloon material located from the proximal edge of the distal markerband extending across the balloon material.There were no other issues noted with the device.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
Note: this report pertains to one of two nephromax dilatation catheter used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax dilatation catheter was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst under 20 atm which caused a lot of bleeding to the patient.Reportedly, the patient stayed at the hospital for one week before being discharged.The same issue occurred with the second nephromax dilatation catheter.The percutaneous nephrolithotomy procedure was cancelled.
Additional Manufacturer Narrative
Additional information: block b5 block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: a visual examination of the returned complaint device confirmed that the balloon was unfolded and had been subjected to positive pressure.A longitudinal tear was also noted at the balloon material located from the proximal edge of the distal markerband extending across the balloon material.There were no other issues noted with the device.This failure is likely due to factors or conditions related to procedure during the use of the device that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
Note: this report pertains to one of two nephromax dilatation catheter used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax dilatation catheter was used in a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the balloon burst under 20 atm which caused a lot of bleeding to the patient.Reportedly, the patient stayed at the hospital for one week before being discharged.The same issue occurred with the second nephromax dilatation catheter.The percutaneous nephrolithotomy procedure was cancelled.***additional information received on 29apr2019*** it was reported that the device was used in the nephrostomy tract.Reportedly, the bleeding was treated by pressure blood transfusion.The patient condition at the conclusion of the procedure was reported to be okay.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8437579
• Report Number: 3005099803-2019-01210
• Device Sequence Number: 277929
• 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,Followup
• Report Date (Section B): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0022417565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/29/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/22/2019; 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization