MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION URETERAL CATHETER; CATHETER, URETHRAL

Model Number	M0064002111
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 flexima ureteral catheter was used in the ureteral orifice during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, when the physician inserted the device, he noticed a linear burr on the cone portion of the catheter which caused a cut in the ureteral orifice of the patient.Reportedly, the patient experienced bleeding and they had to put pressure on the site to stop the bleeding.And the procedure was completed at this time.The patient was reported to have fully recovered.
Event or Problem Description
It was reported to boston scientific corporation that a flexima uereteral catheter was used in the ureteral orifice during a ureteroscopy procedure performed on (b)(6) 2021.During the procedure, when the physician inserted the device, he noticed a linear burr on the cone portion of the catheter which caused a cut in the ureteral orifice of the patient.Reportedly, the patient experienced bleeding and they had to put pressure on the site to stop the bleeding.And the procedure was completed at this time.The patient was reported to have fully recovered.
Additional Manufacturer Narrative
Additional information: block d7 (sud reprocessed and reused?) and block h8 (usage of device).Block h6: patient code e2009 captures the reportable event of a tear in the patient ureter.Device code a0203 captures the reportable event of linear burr found on the cone portion of the catheter.Block h10: the device has not been received for analysis.Upon receipt and 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 flexima uereteral catheter was used in the ureteral orifice during a ureteroscopy procedure performed on june 3, 2021.During the procedure, when the physician inserted the device, he noticed a linear burr on the cone portion of the catheter which caused a cut in the ureteral orifice of the patient.Reportedly, the patient experienced bleeding and they had to put pressure on the site to stop the bleeding.And the procedue was completed at this time.The patient was reported to have fully recovered.
Additional Manufacturer Narrative
Block h6: patient code e2009 captures the reportable event of a tear in the patient ureter.Device code a0203 captures the reportable event of linear burr found on the cone portion of the catheter.Block h10: investigation results: a visual examination of the returned complaint device found that the tip of the device have a sharp burr and a flash, which confirms the reported event.Dimensional inspection of the catheter was within specification.Therefore the reported problem was confirmed.The most probable root cause is quality control deficiency.An investigation to address this problem will be created.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.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12074907
• Report Number: 3005099803-2021-03100
• Device Sequence Number: 3428435
• Product Code: GBM
• UDI-Device Identifier: 08714729342168
• UDI-Public: 08714729342168
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K870694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2021

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: 04/27/2024
• Device Model Number: M0064002111
• Device Catalogue Number: 400-211
• Device Lot Number: 0027220200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 07/29/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/29/2021; 08/23/2021
• 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: Required Intervention