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

Model Number	M0062101620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
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 dilatation balloon catheter kit was unpacked for a percutaneous nephrolithotomy (pcnl) procedure on (b)(6) 2019.According to the complainant, during unpacking, it was noted that a cream colored residue was found on the balloon.Reportedly, this was found prior to use with a patient or procedure.The procedure was completed with another nephromax dilatation balloon catheter kit.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter kit was unpacked for a percutaneous nephrolithotomy (pcnl) procedure on (b)(6) 2019.According to the complainant, during unpacking, it was noted that a cream colored residue was found on the balloon.Reportedly, this was found prior to use with a patient or procedure.The procedure was completed with another nephromax dilatation balloon catheter kit.
Additional Manufacturer Narrative
Problem code 2969 captures the reportable issue of foreign matter.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.

• Brand Name: NEPHROMAX KIT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9202137
• Report Number: 3005099803-2019-05087
• Device Sequence Number: 2951002
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K121614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 09/30/2021
• Device Model Number: M0062101620
• Device Catalogue Number: 210-162
• Device Lot Number: 0022882290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1