MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DUAL LUMEN URETERAL CATHETER; CATHETER, UROLOGICAL

Model Number	M0064051000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
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 dual lumen ureteral catheter was used during a procedure performed on (b)(6) 2019.According to the complainant, the catheter fell apart.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: block b5, e1, h10 block d4, h4: the complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.Block h6: problem code 1069 captures the reportable event of catheter break.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Block h11: correction: bsc aware date is 08 jul 2019 based on the additional information received on 05 aug 2019.
Event or Problem Description
It was reported to boston scientific corporation that a dual lumen ureteral catheter was used during a procedure performed on (b)(6) 2019.According to the complainant, the catheter fell apart.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on 05aug2019 note: this report pertains to one of two dual lumen ureteral catheters used in the same patient and procedure.It was reported to boston scientific corporation that two dual lumen ureteral catheters were used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, the y-junction of the catheter break apart and both of the tips fell off.The same issue occurred with the second dual lumen ureteral catheter.There were no patient complications reported as a result of this event.

• Brand Name: DUAL LUMEN URETERAL CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8841799
• Report Number: 3005099803-2019-03853
• Device Sequence Number: 19208584
• Product Code: KOD
• UDI-Device Identifier: 08714729012689
• UDI-Public: 08714729012689
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K860337
• 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,Followup
• Report Date (Section B): 08/26/2019

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: M0064051000
• Device Catalogue Number: 405-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1