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	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(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 flexima ureteral catheter was used during a procedure performed on an unknown date.According to the complainant, it was noted that the catheter was broken.Reportedly, this event happened five years ago with dr.Gilbert.

• 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: 8332383
• Report Number: 3005099803-2019-00619
• Device Sequence Number: 53542
• 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): 02/12/2019

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: 02/12/2019
• Patient Sequence Number: 1