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

Model Number 0692

Device Problems Component(s), broken (1103); Contamination /Decontamination Problem (2895); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Boston scientific received information that during an implant procedure, a guidewire was unable to advanced down this right ventricular (rv) lead.Eventually the rv lead was implanted but it was observed afterwards that the lead had dislodged.A revision procedure was performed and the physician was not able to advance a stylet all the way into the lead due to blood inside the stylet hole.The physician also noted some difficulty in retracting and extending the helix.The rv lead was eventually explanted and replaced.The lead is no longer in service and there were no additional adverse patient effects reported.

Event Description

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Manufacturer Narrative

(b)(4).The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, the helix of this lead was found to be bent and could no longer retracting into the housing of the lead any longer.It is unknown if the bent helix contributed to the dislodgement or was induced in the field during the explant procedure.Analysis could not confirm any dislodgement or stylet advancement difficulty allegations.The stylet which was returned inserted into the lead was bent in a few places causing slight resistance to be felt but was able to be advanced normally.While blood and body fluid was noted in the helix housing of the lead, there was no blood noted in the lumen.

• Brand Name: ENDOTAK RELIANCE
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4144299
• MDR Text Key: 4765575
• Report Number: 2124215-2014-17709
• 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,Followup
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2016
• Device Model Number: 0692
• Other Device ID Number: RELIANCE 4-FRONT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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; MISMATCH; F162
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention