MAUDE Adverse Event Report: OSCOR INC. HELIOS, 5F UN-SHROUDED; ELECTRODE, PACEMAKER, TEMPORARY

Model Number H05110U

Device Problem Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.

Event Description

The customer reported there was an alleged material-related incident during a cardiac intervention (tf tavi) with an oscor flow directed pacemaker lead.After consultation with the user (senior physician of the anesthesia), we can describe the procedure as follows: before the intervention, during the initiation phase, the oscor helios temporary pacemaker lead was washed as regular and positioned.It achieved perfect function and a threshold of 0.5 v after positioning.During the routine check, prior to the planned rapid pacing, all of a sudden there was no longer a signal.Due to several attempts of troubleshooting (including changing the transfer cable, and changing the pacemaker unit) there was approximately a 20 minute procedure delay.The pacing lead was exchanged with a competitors lead, and the unit was used to ensure the functionality again and continued the intervention.The customer does not know the lot number of the oscor helios lead used for this procedure.There was no adverse impact to the patient and no extended hospitalization.The lead was returned for evaluation.

Manufacturer Narrative

The following sections were updated in follow-up 1: b3, b4, g4, g7, h2, h3, h6, h10, and h11.The device was in use for treatment.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product to pass all in-process and qa final inspection before shipping to the customer.One helios 5f unshrouded temporary pacing lead was received back from the customer.There were no other accessories.Blood was found on the lead.The balloon was broken and damaged.The rest of the lead looked normal.The lead was tested with a multimeter.Both the bipolar resistance and the isolation resistance were within specifications.The positive bipolar resistance was not within specifications because it did not exhibit any electrical activity.When the black connector pin was viewed under a 10x microscope, it was found that the green conductor wire was fractured under the shrink tubing which would account for the lack of electrical activity.It is unknown if an extension cable was used or if the connectors were inserted directly into the external pacemaker.Due to the condition in which the lead was received it is believed that this device may have been subjected to excessive forces and/or excessive manipulation in the field causing the black connector wire to fracture underneath the insulation.No manufacturing defects were found during analysis.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.Corrected data: b3 oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: HELIOS, 5F UN-SHROUDED
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 8678376
• MDR Text Key: 147354784
• Report Number: 1035166-2019-00048
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H05110U
• Device Catalogue Number: H05110U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1