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

Model Number	M0064002010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a flexima open end ureteral catheter device was used in the bladder during a cystoscopy stent exchange procedure performed on (b)(6) 2022.During the procedure, a scope was placed using a single bridge and the catheter was inserted along with the guidewire.The catheter was then pulled back out leaving the guidewire and a stent was placed over the wire; however, a broken piece of the blue open end catheter came into view while inserting the stent.The broken piece was retrieved; however, a second small piece was noticed while emptying the bladder and was retrieved.It was reported that an x-ray and visual inspection using scope were performed which confirmed that no remaining pieces were left inside the bladder and all the broken pieces of the catheter were successfully retrieved.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Weight: it was reported that the patient's weight is 65.1 kg.Report source: medwatch number is mw5111412.(b)(4).
Additional Manufacturer Narrative
Block a4: it was reported that the patient's weight is 61.5 kg.Block g2: medwatch number is mw5111412.Block h6: medical device code a0401 captures the reportable event of catheter break requiring retrieval.Block h11: correction: block e1 (initial reporter address 1 and initial reporter zip/post code) and h10 (patient's exact weight).
Event or Problem Description
It was reported to boston scientific corporation that a flexima open end ureteral catheter device was used in the bladder during a cystoscopy stent exchange procedure performed on (b)(6) 2022.During the procedure, a scope was placed using a single bridge and the catheter was inserted along with the guidewire.The catheter was then pulled back out leaving the guidewire and a stent was placed over the wire; however, a broken piece of the blue open end catheter came into view while inserting the stent.The broken piece was retrieved; however, a second small piece was noticed while emptying the bladder and was retrieved.It was reported that an x-ray and visual inspection using scope were performed which confirmed that no remaining pieces were left inside the bladder and all the broken pieces of the catheter were successfully retrieved.There were no patient complications reported as a result of this event.

• Brand Name: URETERAL CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15475223
• Report Number: 3005099803-2022-05244
• Device Sequence Number: 19551621
• Product Code: KOD
• UDI-Device Identifier: 08714729751571
• UDI-Public: 08714729751571
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: 07/12/2025
• Device Model Number: M0064002010
• Device Catalogue Number: 400-201S
• Device Lot Number: 0029754017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female