MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0282

Device Problems Component(s), broken (1103); Fracture (1260); High impedance (1291); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

Boston scientific received information that during an implant procedure, this right ventricular (rv) lead was inserted into the patient and it was difficult to advance the lead past the tricuspid valve.A new stylet was used and the rv lead was placed successfully.Under fluoroscopy, the physician noted that the distal tip of the rv lead was fractured.A high pacing impedance measurement of over 2000 ohms was also observed.The physician believed that the tip of the lead was caught between the stylet and the patient¿s tissue, which contributed to the fracture.The rv lead was explanted and replaced, and with a new lead, the rest of the implant procedure proceeded as planned.The old rv lead was never in service.No adverse patient effects were reported.

Manufacturer Narrative

(b)(4).The rv lead was kept by the hospital and will not be returned for analysis.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: ENDOTAK RELIANCE
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4140185
• MDR Text Key: 15120347
• Report Number: 2124215-2014-17601
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2015
• Device Model Number: 0282
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2013
• 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: 4479; 4542; 0282; P162
• Patient Age: 75 YR