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

Catalog Number 03.804.701S

Device Problems Difficult to Advance (2920); Mechanical Jam (2983)

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

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(4).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product or any subcomponents that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.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 during an initial balloon assisted vertebral body augmentation on (b)(6) 2016; the synflate balloon was not functioning properly.The balloon was not going down the access needle.There was no surgical delay and the procedure was completed successfully.The patient's postsurgical outcome was excellent.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

A product investigation was completed: upon inspection of the returned instrument, debris could be seen in the balloon indicating that the balloon was most likely used at least once.However, the complaint condition cannot be replicated without the holding sleeve so the complaint cannot be confirmed.No definitive root cause could be determined based on the complaint description however there is a chance that the proper procedures for reuse were not followed.A visual inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The small synflate balloon (03.804.702s) 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 the reuse the balloon catheter: the synflate balloon catheter may be reused once within the surgery.For balloon catheter reuse, remove the inflation system and carefully insert the catheter back into the white cover sleeve to properly refold the balloon.Since the first inflation may stretch the balloon material, the length may become larger than the original length.Therefore always insert the catheter under fluoroscopic control.Relevant drawing for the instrument was reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instrument¿s lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots numbers which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: SYNFLATE BALLOON/MEDIUM- STERILE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5688754
• MDR Text Key: 46205252
• Report Number: 3000270450-2016-10127
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 03.804.701S
• Device Lot Number: 0915069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR