MAUDE Adverse Event Report: SYNTHES SELZACH SYNFLATE BALLOON/MEDIUM-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.701S

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information not available for reporting.Event date: unknown.Additional product code: hrx.(b)(4).Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review ¿ manufacturing site: (b)(4).Supplier: (b)(4).Manufacturing date: 07 october 2015.Expiry date: 31july 2017.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that two (2) synflate balloons malfunctioned during a vertebral body augmentation at l1.One (1) synflate balloon burst and was removed from the patient, then drained of saline causing an approximate 30 second delay.The other synflate balloon could not be removed from a canula.The canula was removed and the balloon was cut out, causing a minute delay.Additional x-rays were taken.The procedure was completed without further incident.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.It was reported balloon was unable to be removed from the cannula, as a result the cannula was removed and the balloon cut out; this caused a one minute delay.The assembly (03.804.701s lot 0615048) was returned with a cut catheter shaft; the balloon was intact.The complaint condition was confirmed.The synflate balloon/medium (03.804.701s) is a component of the synflate system which is a balloon-based vertebral augmentation system utilized for vertebral compression fractures and osteolytic lesions.The system technique guide notes the following regarding balloon inflation and removal: ¿ proceed with inflation slowly, stopping every few seconds to allow the bone to adjust to the pressure/volume changes.¿ the balloons may leak or burst if they are filled beyond their maximum volume or pressure.¿ ¿ if it becomes difficult to remove the balloon catheter through the working sleeve, twist the catheter while firmly pulling the catheter.¿ if removal is still difficult, remove the balloon catheter(s) along with the working sleeve(s), then re-access the vertebral body using the working sleeve with the trocar assembly.Once the re-access is completed, remove the trocar.The relevant drawings for the returned device was reviewed.The design and materials were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument lot number and no mrrs, ncrs or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.No definitive root cause was able to be determined based on the complaint description.Burst balloons are often related to inflation technique or contact with sharp biology.Additionally, difficulty in removing balloons is often related to technique.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNFLATE BALLOON/MEDIUM-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5288851
• MDR Text Key: 33261810
• Report Number: 3000270450-2015-10249
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 0615048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention