MAUDE Adverse Event Report: OSCOR INC. 44 S FLEXION PERMANENT PACING LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4015

Device Problems Fracture (1260); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available-evaluation in progress.

Event Description

Out-of-service reporting form completed by: (b)(6).Affected device: rvdr01/(b)(4) affected leads: 4015/(b)(4) and 4017/(b)(4).Indications for procedure: lead replacement for lead malfunction.

Manufacturer Narrative

The device was in use for treatment.Returned device analysis reveals a lead with extensive physical damage incurred during extraction.The condition of the lead prior to explantation cannot be determined.An 8 cm segment of the proximal end and a 39.3 cm segment of the distal end of a flexion lead was received back from the customer.Dried blood was found on and inside the insulation and tip assembly.The connector pin was capped and the cap was secured to the lead with suture string.An extraction device was attached to the end of the distal segment of the lead.The inner and outer lumen of the lead was abraded and there were many cuts and nicks throughout the entire length.The cut that severed the lead in half was not clean and even.The coils were twisted, stretched out, kinked and some were broken.The electrical values were tested on the lead segments with a multimeter and there is no electrical activity on the distal end and the values fluctuated rapidly on the proximal end.The lead segments were inspected under a microscope, using 10x magnification and it was found that some of the coils were twisted, stretched out, kinked and broken.The electrical values were tested with a multimeter and the proximal segment is still electrically active with rapidly fluctuating values, but distal end showed no electrical activity.The reason for return was confirmed, however, no manufacturing defects were found.There is no allegation that the device failed to meet its performance specifications.Based on the investigation, a capa is not required.This lead is no longer manufactured by oscor.Oscor will continue to monitor this device for complaint trends and risk.The event will be re-evaluated if additional information becomes available.Per quality assurance procedure permanent pacing lead final inspection indicates that the lead is checked 100% for electrical function.Final qa inspection of permanent pacing leads includes an insertion/withdrawal force test on is-1 connector on the first and last serial number of the work order and 100% inspection regarding: length measurement of the lead, distal spacing measurement, pull test on the connector, electrical dc resistance is checked ring to ring, pin to tip and pin to ring (on pr leads, helix to connector pin used as contact), "d" dimension on is-1 connector is measured and tubing inspection is done.A general inspection is done of the following: verify proper application of adhesive, check outer hull to inner hull laser weld for proper placement, coil is checked for kinks, the connector sleeve and o-rings are examined for nicks, cuts, excessive flash or excessive adhesive residues on its surface, electrodes are examined for residue and scratches, rotational pin to pin hull laser weld is checked for proper weld, and helix is checked by extension and retraction.Prior to packaging the helix is completely retracted and protector tubing is attached.Although the root cause of this failure could not be determined, potential causes of this failure may be: unsatisfactory electrode position or damaged coating on tip during implant.The potential effects from this type of failure include: less efficient pacing, more frequent battery replacement, intermittent or continuous loss of pacing or sensing, or another procedure may be required for repositioning or removal.Per instructions for use (ifu) it informs the user of possible complications: with the use of endocardial leads, complications might occur during implantation, explantation, or at any time postoperatively and may require non-invasive or invasive techniques for management, as determined by the clinical judgment of the physician.Intermittent or continuous loss of pacing or sensing can be caused by a displacement of the electrode, unsatisfactory electrode position, breakage of the conductor or its insulation, an increase in thresholds, or poor electrical connection to the pulse generator.

Event Description

Additional information received on 7/24/2017 the lead was capped in 2011 due to lead fracture.

• Brand Name: 44 S FLEXION PERMANENT PACING LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6724831
• MDR Text Key: 80625489
• Report Number: 1035166-2017-00063
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• PMA/PMN Number: K964107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4015
• Device Catalogue Number: 4015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR