MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-11-23 for KYPHX XPANDER INFLATABLE BONE TAMP, SIZE 15/3 K09A manufactured by Medtronic Spine Llc.
[17726625]
It was reported that during a single level kyphoplasty procedure, the balloon was deflated, but the physician was unable to remove it from the vertebral body. The physician had to pull on the balloon which caused the tubing to break apart causing the radiopaque dots to stay in the pt. After removing the cannula and applying some force, the physician was able to remove everything from the pt with no complications reported. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[17909912]
F/u conversation with company rep. Conclusion: the visual review does indicate that the catheter outer shaft has been torn and broken away from the balloon. Also the inner shaft has been stretched significantly and has been torn off prior to where the two marker bands would have been located. There is no balloon attached to the catheter. Based on the above visuals, it may be assumed that the balloon was unable to be removed through the cannula and after pulling on the catheter, both inner and outer shafts broke off proximal to the balloon, and the balloon has been disconnected from the catheter. The balloon being torn off from the rest of the catheter could have been caused by the balloon getting snagged on a sharp bone shard, or the balloon was unable to deflate completely causing it to not thread through the cannula.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953769-2009-00172 |
| MDR Report Key | 1545949 |
| Report Source | 05,07 |
| Date Received | 2009-11-23 |
| Date of Report | 2009-10-26 |
| Date of Event | 2009-10-26 |
| Date Mfgr Received | 2009-10-26 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2009-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL ARMSTRONG, SR DIR |
| Manufacturer Street | 1221 CROSSMAN AVE. |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4085486500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHX XPANDER INFLATABLE BONE TAMP, SIZE 15/3 |
| Generic Name | INFLATABLE BONE TAMP |
| Product Code | HXG |
| Date Received | 2009-11-23 |
| Returned To Mfg | 2009-11-12 |
| Model Number | NA |
| Catalog Number | K09A |
| Lot Number | 01039363 |
| ID Number | NA |
| Device Expiration Date | 2011-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SPINE LLC |
| Manufacturer Address | 1221 CROSSMAN AVE. SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-23 |