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

Model Number M0062101620

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

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 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 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.

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
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9202137
• MDR Text Key: 177561441
• Report Number: 3005099803-2019-05087
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729834526
• UDI-Public: 08714729834526
• Combination Product (y/n): N
• PMA/PMN Number: K121614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1