MAUDE Adverse Event Report: CPI - DEL CARIBE ACUITY; IMPLANTABLE LEAD

Model Number 4671

Device Problems Difficult To Position (1467); Device Contamination With Biological Material (2908); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory a technician attempted to insert a stylet into the terminal area, without success.During testing, the foreign matter that was in the lead moved down to approximately six centimeters from the distal tip.The insulation was then cut open to visualize the foreign matter.Analysis determined the foreign matter was likely an agglomerate of blood and body fluid along with polymer from the lead and guidewire interaction.

Event Description

Boston scientific received information that during the implant procedure the physician experienced difficulty implanting this lead.On the second attempt, the physician placed the lead in new vessel, however the stylet became stuck and the lead's lumen became blocked with foreign matter.The lead was attempted and not implanted.No adverse patient effects were reported.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7410845
• MDR Text Key: 104923582
• Report Number: 2124215-2018-05900
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: 4671
• Other Device ID Number: ACUITY X4 STRAIGHT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2017
• 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: 0184; 0292; 4135; 4136; 4543; 4592; 4671; 4672; 7741; E110; G247; N119
• Patient Age: 68 YR