MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGEVITY+; IMPLANTABLE LEAD

Model Number 7841

Device Problem Difficult to Insert (1316)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 12/28/2022

Event Type  Injury  

Event Description

It was reported the during the implant for right ventricular (rv) lead there was placement difficulty.The physician was trying to insert the lead using a sheath without a check valve, but the lead could not pass well.When the physician changed the sheath, it was suspected that the lead was not an issue.The physician tried few times on puncture; however, the patient was on dialysis, he could not stop bleeding and the blood pressure dropped.As a result, the physician ended the procedure.The lead is not expected to return for analysis.

Event Description

It was reported the during the implant for right ventricular (rv) lead there was placement difficulty.The physician was trying to insert the lead using a sheath without a check valve, but the lead could not pass well.When the physician changed the sheath, it was suspected that the lead was not an issue.The physician tried few times on puncture; however, the patient was on dialysis, he could not stop bleeding and the blood pressure dropped.As a result, the physician ended the procedure.The lead is not expected to return for analysis.

Manufacturer Narrative

This report contains additional information in section b7 other relevant history and h6 impact codes.

Event Description

It was reported the during the implant for right ventricular (rv) lead there was placement difficulty.The physician was trying to insert the lead using a sheath without a check valve, but the lead could not pass well.When the physician changed the sheath, it was suspected that the lead was not an issue.The physician tried few times on puncture; however, the patient was on dialysis, he could not stop bleeding and the blood pressure dropped.As a result, the physician ended the procedure.The lead is not expected to return for analysis.

• Brand Name: INGEVITY+
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16104260
• MDR Text Key: 306723437
• Report Number: 2124215-2023-00315
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00802526604577
• UDI-Public: 00802526604577
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150012/S083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7841
• Device Catalogue Number: 7841
• Device Lot Number: 1219863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female