MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY CATHETER SETS; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0064201110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The complainant indicated that the device will not be returned for investigation.Therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access set was used in the kidney during a percutaneous nephrostomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was used as a micropuncture system; however, the indication for use of the device is for percutaneous nephrostomy.Reportedly, this event caused delay to the procedure which resulted to pain and bleeding of the patient.The reported injury does not require further medical intervention and the procedure was completed with another percutaneous access set.Additionally, it was confirmed that there was no issue noted on the device.The patient condition at the conclusion of the procedure was reported to be stable.

• Brand Name: NEPHROSTOMY CATHETER SETS
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8570927
• Report Number: 3005099803-2019-02326
• Device Sequence Number: 13837136
• Product Code: GBO
• UDI-Device Identifier: 08714729009733
• UDI-Public: 08714729009733
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K820867
• 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
• Report Date (Section B): 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: M0064201110
• Device Catalogue Number: 420-111
• Device Lot Number: 0019968059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR