MAUDE Adverse Event Report: TERUMO CORP. SINGLE USE GUIDEWIRE

Model Number	G-240-2545S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Respiratory Failure (2484); Pneumoperitoneum (4819)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled " endoscopic ultrasound-guided gallbladder drainage: beyond cholecystitis.".Literature summary: endoscopic ultrasound-guided gallbladder drainage (eus-gbd) is an alternative to surgery for acute cholecystitis (ac) in poor operative candidates.However, the role of eus-gbd in non-cholecystitis (nc) indications has not been well studied.We compared the clinical outcomes of eus-gbd for ac and nc indications.Consecutive patients undergoing eus-gbd for all indications at a single center were retrospectively analyzed.Fifty-one patients underwent eus-gbd during the study period.Thirty-nine (76%) patients had ac while 12 (24%) had nc indications.Nc indications included malignant biliary obstruction (n = 8), symptomatic cholelithiasis (n = 1), gallstone pancreatitis (n = 1), choledocholithiasis (n = 1), and mirizzi¿s syndrome (n = 1).Technical success was noted in 92% (36/39) for ac and 92% (11/12) for nc (p > 0.99).The clinical success rate was 94% and 100%, respectively (p > 0.99).There were four adverse events in the ac group and 3 in the nc group (p = 0.33).Procedure duration (median 43 vs.45 min, p = 0.37), post-procedure length of stay (median 3 vs.3 days, p = 0.97), and total gallbladder-related procedures (median 2 vs.2, p = 0.59) were similar.Eus-gbd for nc indications is similarly safe and effective as eus-gbd in ac.Type of adverse events/number of patients: abdominal pain with hospitalization - 1 patient; bleeding requiring transfusions - 1 patient; bleeding requiring embolization of the gastroduodenal artery - 1 patient; pneumoperitoneum requiring exploratory laparotomy ¿ 1 patient; pneumoperitoneum requiring supportive care with intravenous fluids and antibiotics ¿ 1 patient; respiratory failure requiring ventilation and additional stay in the intensive care unit ¿ 1 patient; cholecystocolonic fistula requiring stent removal and gastric clips for closure ¿ 1 patient.Two patients had reportedly died.It was reported these deaths were unrelated to procedures or the devices in use during the procedures.This literature article requires 2 reports.The related patient identifiers are as follows: -b)(6): gf-uct180 evis exera ii ultrasound gastrovideoscope; (b)(6): g-240-2545s single use guidewire.This medical device report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: SINGLE USE GUIDEWIRE
• Manufacturer (Section D): TERUMO CORP.; 44-1, 2-chome, hatagaya; shibuya-ku, tokyo 151-0 072; JA 151-0072
• MDR Report Key: 17556570
• Report Number: 2429304-2023-00259
• Device Sequence Number: 5045611
• Product Code: OCY
• UDI-Device Identifier: 04953170282782
• UDI-Public: 04953170282782
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2023
• Report Date (Section F): 07/18/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: G-240-2545S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GF-UCT180 EVIS EXERA II GASTROVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown