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

Model Number	M0062101170
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used in the right kidney during a percutaneous nephrolithotomy (pnl) procedure performed in the colon on (b)(6) 2020.According to the complainant, it was noticed that the distal tip of the balloon catheter was twisted when preparing the balloon.The procedure was completed with another nephromax dilatation balloon catheter.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
Block h6: problem code 2981 captures the reportable issue of distal tip bent.Block h10: investigation result a visual examination of the complaint device found the balloon was not folded which indicates that the device was subjected to positive pressure.The balloon and the tip of the catheter were visually and microscopically examined, and no issues were noticed, thereby the reported event of tip bent was not confirmed.The catheter shaft was also noted kinked near at the distal section of the device.It is most likely that the reported failure is due to excessive force being applied to the device when handling, during preparation for the procedure, which is advised against in the dfu.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 instructions for use (ifu)/product label.Block h11: correction: block b5, d4 (lot number and expiration date) and h4.
Event or Problem Description
It was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used in the right kidney during a percutaneous nephrolithotomy (pnl) procedure performed in the colon on (b)(6) 2020.According to the complainant, it was noticed that the distal tip of the balloon catheter was twisted when preparing the balloon.The procedure was completed with another nephromax dilatation balloon catheter.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.**correction** it was reported to boston scientific corporation that a nephromax dilatation balloon catheter was used during a percutaneous nephrolithotomy (pnl) procedure performed in the right kidney on (b)(6) 2020.

• Brand Name: NEPHROMAX
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10570576
• Report Number: 3005099803-2020-04118
• Device Sequence Number: 19534016
• Product Code: LJE
• UDI-Device Identifier: 08714729012641
• UDI-Public: 08714729012641
• 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): 10/27/2020

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: 02/06/2022
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 0023308914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR