MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTRODUCER NEEDLES; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	M0067001210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pneumonia (2011)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2019.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf impact code f2303 captures the reportable event of medication required.
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced pneumonia.The patient was given antibiotics for c.Difficile and pneumonia.
Event or Problem Description
It was reported to boston scientific corporation that a percutaneous access needle was used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced pneumonia.The patient was given antibiotics for c.Difficile and pneumonia.Additional information received on (b)(6) 2023: it was reported that in addition to pneumonia, the patient experienced pseudomembranous colitis and was given antibiotics for c.Difficile infection.
Additional Manufacturer Narrative
Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in november 2019.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h2: additional information: block b5 (describe event or problem) and block h6 (patient codes) have been updated based on the additional information received on march 20, 2023.Block h6: imdrf patient code e0733 captures the reportable event of pneumonia.Imdrf patient code e2326 captures the reportable event of pseudomembranous colitis.Imdrf impact code f2303 captures the reportable event of medication required.

• Brand Name: INTRODUCER NEEDLES
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 16362719
• Report Number: 3005099803-2023-00474
• Device Sequence Number: 17827348
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K820867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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: M0067001210
• Device Catalogue Number: 700-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Race: White