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

Model Number M0067001210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 03/01/2019

Event Type  Injury  

Event Description

Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced abscess, requiring percutaneous drainage antibiotics.

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 upn lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient code e172001 captures the reportable event of abscess.Imdrf impact codes f19, and f2303 captures the reportable event of surgical intervention and medication required.

Event Description

Note: this report pertains to one of two devices used in the same patient and procedure.It was reported to boston scientific corporation that a nephromax balloon and percutaneous access needle were used during a percutaneous nephrolithotomy procedure performed in (b)(6) 2019.The patient experienced abscess, requiring percutaneous drainage antibiotics.Additional information received on april 3, 2023: it was reported that the patient experienced retroperitoneal abscess, requiring percutaneous drainage and antibiotics.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 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 h10 (additional mfr narrative) have been updated based on the additional information received on april 3, 2023.Block h6: imdrf patient code e172001 captures the reportable event of retroperitoneal abscess.Imdrf impact codes f19, and f2303 captures the reportable event of surgical intervention and medication required.

• Brand Name: INTRODUCER NEEDLES
• Type of Device: 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: 16333539
• MDR Text Key: 309128897
• Report Number: 3005099803-2023-00593
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 08714729077749
• UDI-Public: 08714729077749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: M0067001210
• Device Catalogue Number: 700-121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Race: Asian