MAUDE Adverse Event Report: OSCOR INC TEMPORARY MYOCARDIAL HEARTWIRE; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

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.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 itsemployees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

Event Description

Pacer wires were being removed at the bedside; atrial wire removed without issue, provider met resistance with ventricular pacer wire, asked for additional help from surgeon.Surgeon was able to remove the wire but noted it appeared incomplete in comparison to atrial wire after removal.Imaging taken to confirm.Decision was made to leave wire fragment in place.No additional information is available.No patient harm reported.

Manufacturer Narrative

There was no allegation reported against the device.The lead was broken during extraction by the physician.The broken fragment of the device was left inside the patient.No implant date was provided for the device.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 itsemployees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

Manufacturer Narrative

The following sections were updated in follow-up 1.B4, g3, g6, h2, h6 & h10.The device was discarded by the customer and not returned for analysis.The investigation was focused on a review of product documentation.The device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.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 pass all in-process and qa final inspection before shipping to the customer.The following controls are in place to mitigate the reported product issue.Per zig-zag heartwire package inspection, 5.3 verify presence of zig-zag with no broken wire strands.The length of the zig-zag is approximately 10mm.The zig-zag should be at the distal cathode electrode not more than 2 mm away from the insulation.Sample to verify zig-zag length according to ansi z1.4 general level 2 aql 1.0 5.5 the heartwire should be wound around the plate snuggly, but not so tight as to stretch out the zig-zag.The heart needle should be placed through the silicone tubing at a horizontal position insuring that the needle tip will not perforate the pouches.Insure proper pins with adaptors are present per ifu :2 leaving the heartwire implanted for longer than 7 days may result in difficulty or inability to extract the lead and/or bleeding directions for use: a.(1) unipolar heartwire or quadripolar (4x unipolar) heartwire- the distal end of the unipolar temporary heartwire is embedded in the desired portion of the myocardium (atrial or ventricular) using the small curved needle.It is important that the electrode (zig-zag wire or the exposed wire just before the tines) be implanted in the myocardium, i.E., the electrode should not be visible for tined heartwires pull the heartwire through the myocardium until the tines are exposed.Pull back on the heartwire body until the tines are stabilized on top of the epicardium a.(2) bipolar heartwire or quadripolar (2x bipolar) heartwire- the distal bipolar end of the temporary pacing wire is embedded in the desired portion of the myocardium (atrial or ventricular) using the small curved needle.Both electrodes should not be visible.The preferred technique employs two passes of the needle resulting in the insulation between electrodes being visible for tined heartwires pull the heartwire through the myocardium until the tines are exposed.Pull back on the heartwire body until the tines are stabilized on top of the epicardium caution: the temporary heartwires must be placed in such a way that moderate traction will remove it when appropriate no further follow-up is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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: TEMPORARY MYOCARDIAL HEARTWIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: denail naut ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 15242622
• MDR Text Key: 299281464
• Report Number: 1035166-2022-00099
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 7 KG