MAUDE Adverse Event Report: OSCOR INC. HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON; TEMPORARY PACING LEAD

Model Number H05RH110U

Device Problem Inflation Problem (1310)

Patient Problems Complete Heart Block (2627); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device was in use for treatment.The returned device passed visual inspection.There was no damage to the balloon or the balloon straps.The returned device passed balloon inflation/deflation test.The balloon was inflated and deflated over 10 cycles with no difficulty.No problem was identified with the returned helios temporary bipolar pacing lead with balloon.Although root cause could not be determined as to why the balloon would not inflate for the user, there exists a possibility of use error.Per conversation with the customer, an inservice is scheduled for this (b)(6) on use of the device.A review of the device history record identified rejects in final packaging for eight units with incorrect date of manufacture on the barcode and eight units for no english title on the label.A review of complaints against this lot number identified one additional complaint for balloon burst which is associated with this event.Per qa final inspection procedure prior to shipment to the customer, 100% of devices are subjected to visual inspections of balloon material in the inflated and deflated state, visual inspection of balloon straps, inspection of bonding of the inflation lumen, inflation/deflation capability of the balloon, the ability of balloon to maintain inflated state for a minute and leak test of the inflated balloon.The instructions for use (ifu) provides these possible complications and warnings: although temporary cardiac pacing has proven to be a feasible emergency procedure, the physician should be aware that certain complications can occur when a temporary pacing lead is introduced, such as myocardial perforation, fibrillation, arrhythmia, pulmonary embolism, and thrombus formation.The balloon rupture, vessel perforation, intimal disruption, and embolism are potential complications in the use of a balloon temporary pacing lead.In addition, the ifu provides instructions on testing of the balloon integrity before use.The user is instructed not to inflate the balloon beyond the stated maximum inflation capacity.Exceeding the maximum inflation capacity will not appreciably increase the diameter of the balloon and can cause balloon rupture.The second helios temporary pacing lead associated with this event is reported under mdr 1035166-2016-00076.

Event Description

The customer reported that during a diagnostic procedure, the patient went into complete heart block (chb) and required a temporary pacer.During testing of the helios temporary pacing lead balloon, the first balloon would not inflate.A second helios device was obtained for use.During testing of the second device, there was difficulty getting the balloon to function so additional air was inserted which resulted in bursting of the balloon.A third device was obtained and functioned without further problems.There was no report of any adverse patient effects from this event.

• Brand Name: HELIOS TEMPORARY BIPOLAR PACING LEAD WITH BALLOON
• Type of Device: TEMPORARY PACING LEAD
• 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 1816
• Manufacturer Contact: jan flegeau ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 5610008
• MDR Text Key: 43717142
• Report Number: 1035166-2016-00080
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Model Number: H05RH110U
• Device Catalogue Number: H05RH110U
• Device Lot Number: C1-10930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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