MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0064101060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima ureteral catheter was used in the kidney during a procedure performed on (b)(6) 2018.According to the complainant, the patient was scheduled for the removal of the drainage catheter.Reportedly, after the procedure, the physician found that the catheter was broken.

• Brand Name: RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8316365
• Report Number: 3005099803-2019-00534
• Device Sequence Number: 2285314
• Product Code: GBO
• UDI-Device Identifier: 08714729005308
• UDI-Public: 08714729005308
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K820867
• 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
• Report Date (Section B): 02/07/2019

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 Model Number: M0064101060
• Device Catalogue Number: 410-106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1