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 Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
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 dilatation catheter device was used in the left kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was inflated and burst within rated pressure.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax balloon dilatation catheter device was used in the left kidney during a percutaneous nephrolithonomy (pcnl) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was inflated and burst within rated pressure.The procedure was completed with another nephromax balloon dilatation catheter device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
(b)(4).Block h10: investigation results: a visual examination of the returned complaint device found that the balloon was tightly folded.It was noted that the device was attached to a boston scientific encore inflation unit and positive pressure was applied.Visual and tactile examination identified a kink in the catheter shaft located approximately 80mm distal of the hub.This type of damage is consistent with an excessive force having been applied to the shaft.No issues were noted with the material of the balloon.No failures were found that could have contributed to the complaint incident.Based on review of this data, this complaint does not represent a new or unanticipated event.Therefore, the most probable root cause for this complaint is no problem detected.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.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8864080
• Report Number: 3005099803-2019-03927
• Device Sequence Number: 19362833
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 06/10/2021
• Device Model Number: M0062101400
• Device Catalogue Number: 210-140
• Device Lot Number: 0022232547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR