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 Problems Hemorrhage/Bleeding (1888); Renal Failure (2041)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.The complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Imdrf patient codes e130501 and e0506 capture the reportable event of acute kidney injury and hemorrhage.Imdrf impact codes f19 and f23 capture the reportable event of surgical intervention and unexpected medical intervention.

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 a percutaneous access needle were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced hemorrhage and acute kidney injury (aki), requiring transfusion and interventional radiology (ir) embolization.

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 a percutaneous access needle were used during a left percutaneous nephrolithotomy procedure performed in (b)(6) 2020.The patient experienced hemorrhage and acute kidney injury (aki), requiring transfusion and interventional radiology (ir) embolization.

Manufacturer Narrative

Block b3: date of event: the exact date is unknown; however, it was reported that the event occurred in (b)(6) 2020.Block d4, h4: the complainant was unable to report the device suspected lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf patient codes e130501 and e0506 capture the reportable event of acute kidney injury and hemorrhage.Imdrf impact codes f19 and f2302 capture the reportable event of surgical intervention and blood transfusion.Block h11: correction - block d4 (model number) has been corrected.Correction - block h6 (impact code) has been corrected.

• 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: 16329386
• MDR Text Key: 309124781
• Report Number: 3005099803-2023-00643
• Device Sequence Number: 1
• Product Code: GBO
• 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: 02/14/2023

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: 02/08/2023
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 02/14/2023
• 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: 79 YR
• Patient Sex: Female
• Patient Race: White