MAUDE Adverse Event Report: OSCOR INC. TB 4F TEMPORARY BIPOLAR PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	020022
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Complete Heart Block (2627)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: country of incident occurrence - (b)(6).Pma 510(k): k861403 and k884866 are both applicable.Additional information has been requested, however not received as of date of this report.Conclusion not yet available as the investigation is on-going.
Event or Problem Description
The customer reported the sonde (catheter) plug had a loose connection and as a result the patient had to be resuscitated.With these sondes a couple problems occur that threaten the life of the patient.In addition there is a loose connection at the plug, so there is no stimulation.This is what happened today in the imc.The patient came with the av block iii°, came directly from the emergency department to the cath lab, immediately received the temporary pacemaker and in spite of the correct position of the sonde (catheter) the patient had to be resuscitated in the imc and an external stimulation by a defibrillator was necessary.It turned out that there was a loose connection of the plug.
Additional Manufacturer Narrative
Device used in treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies recorded in the dhr affecting released product.The released device passed all in-process and qa final inspection steps before shipping to the customer.Capa was previously opened to investigate the root cause and to implement corrective action to prevent recurrence of this issue.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Field action has been initiated for tb lead.The tb leads are inspected visually and tested for electrical continuity 100% by qa prior to shipping to the customer per procedure temporary lead final inspection (model tb).Per instructions for use tb without needle/cannual (ifu) precautions are provided to the user: do not connect to a/c power.Inappropriate connection of exposed pin(s) to an ac power source may pose serious risk of injury or death.Avoid kinking or bending the lead to minimize the risk of damage to internal wires.Avoid subjecting the device to unusual stresses.The device should be stored at temperatures between 5° c (41° f) and 30° c (86° f).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: TB 4F TEMPORARY BIPOLAR PACING LEAD
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 de soto blvd.; palm harbor FL 34683
• MDR Report Key: 7861685
• Report Number: 1035166-2018-00084
• Device Sequence Number: 1445431
• Product Code: LDF
• UDI-Device Identifier: 00836559009900
• UDI-Public: 00836559009900
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 020022
• Device Catalogue Number: 020022
• Device Lot Number: DP-06760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1035166-09/07/2018-01-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention