MAUDE Adverse Event Report: CPI PLANT - ST. PAUL ACUITY; IMPLANTABLE LEAD

Model Number 4671

Device Problems Difficult To Position (1467); Capturing Problem (2891); Device Contamination With Biological Material (2908)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Visual inspection noted dried blood/body fluid noted within the lead lumen.The conductor coil was slightly bent approximately 9mm from the lead tip.Foreign material was observed inside the lead lumen near the tip, approximately 14mm from the tip.The foreign material was likely an accumulation of blood/body fluid and polymer coatings separated from the lead and the guide wire, due to the interaction of the wire within the lumen.Laboratory analysis confirmed the obstruction in the lead lumen.

Event Description

Boston scientific received information that this left ventricular (lv) lead was attempted to be implanted.It was noted the patient anatomy was difficult and there was significant scar tissue.The lead was positioned several times due to high pacing thresholds, until an obstruction was noted near the lead tip and a guide wire would no longer pass.The lead was flushed but this did not clear the obstruction.Anew lead was implanted, also with higher threshold values.No adverse patient effects were reported.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7658315
• MDR Text Key: 113012821
• Report Number: 2124215-2018-11894
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: 4671
• Other Device ID Number: ACUITY X4 STRAIGHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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
• Treatment: 0692; 4671; 7741; G447
• Patient Age: 73 YR