MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿ KIT; CATHETER, NEPHROSTOMY

Model Number	M0062101600
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
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 balloon kit was used during a percutaneous urinary tract stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon ruptured at 18 atmospheric pressure.The procedure was completed with another nephromax balloon kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be no problem.
Additional Manufacturer Narrative
A visual examination of the returned device confirmed that the balloon was unfolded and had been subjected to positive pressure.A blood was noted within the balloon material which is evidence of a device leak.A large circumferential tear was noted in the balloon material distal to the proximal balloon bond.A longitudinal tear was also noted in the balloon material beginning at the circumferential tear and extending distally across the remaining balloon material.There is not enough information to identify what might have caused the reported failure.Therefore the most probable cause for this complaint cannot be determined.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.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
It was reported to boston scientific corporation that a nephromax balloon kit was used during a percutaneous urinary tract stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the balloon ruptured at 18 atmospheric pressure.The procedure was completed with another nephromax balloon kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be no problem.

• Brand Name: NEPHROMAX¿ KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7717735
• Report Number: 3005099803-2018-02416
• Device Sequence Number: 1452141
• Product Code: LJE
• UDI-Device Identifier: 08714729834540
• UDI-Public: 08714729834540
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• 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): 07/13/2018

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: 11/30/2019
• Device Model Number: M0062101600
• Device Catalogue Number: 210-160
• Device Lot Number: 20228676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1