MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-06 for INSPIRA AIR BALLOON CATHETER 10X40MM BC1040A manufactured by Acclarent, Inc..
[16741685]
(updated by acclarent). This event occurred in one pt on (b)(6) 2011. A copy of the facility's 3500a form was sent by the fda to acclarent, and was received by acclarent's mgr of regulatory affairs on (b)(6) 2011. Acclarent's vp of medical affairs was promptly notified, and gathered the following info from the acting physician: the event involved a 10x40mm inspira air device noted to have a portion of the balloon separated from the device upon removal through a bronchoscope. The bronchoscope was noted by the physician to be too small to accommodate the removal of the balloon catheter. The physician noted that force was needed to remove the balloon after it easily deflated. Note, the previous report from the facility's risk mgr stated that the balloon did not or was not deflated. Upon f/u with the physician, he clarified that the inspira air device did deflate; however, the bronchoscope was too small to allow the removal of the balloon catheter. Due to this interference, a portion of the balloon tore and temporarily remained in the bronchus. The portion of the balloon was promptly retrieved. The physician noted that a small tear may have been present in the bronchus from the trauma of removing the balloon. For this reason, the child was kept overnight in the intensive care unit. The pt did well and was discharged with no ill effects. The physician stated that the result from the inspira air dilations on the patient were excellent and no further dilatations have been required. The physician did not feel that there was a malfunction of the inspira air system. Rather, he felt that the problem was merely a size issue of too large a balloon being removed through too small a bronchoscope. The physician was aware that the inspira air is used for dilation of the trachea, and compatibility for use within the working channel of a bronchoscope has not been established. In addition, it should be noted that acclarent's ifu states to never advance or retract the devices against resistance as this could cause tissue trauma or device damage. No device was available for eval. No product malfunction was noted. The lot number provided was reviewed, and was found to meet specification. No negative trend has been identified with this complaint. Acclarent will continue to update the file with any add'l info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: D, B5
[16937574]
Correction to facility's initial report: the previous report from the facility's risk mgr stated that the balloon did not or was not deflated. Upon f/u with the physician, he clarified that no malfunction of the inspira air system took place. He noted that the device did deflate, however, the bronchoscope was too small to allow the removal of the balloon catheter. (inspira air was used within the working channel of the bronchoscope). Note, inspira air's ifu warnings and precautions states the balloon dilation system can be used side by side with a bronchoscope. Compatibility for use within the working channel of a bronchoscope has not been established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2011-00001 |
| MDR Report Key | 2063243 |
| Report Source | 07 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-01-14 |
| Date of Event | 2011-01-11 |
| Date Facility Aware | 2011-01-11 |
| Report Date | 2011-01-14 |
| Date Reported to FDA | 2011-02-01 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2012-06-05 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA AIR BALLOON CATHETER 10X40MM |
| Generic Name | INSPIRA AIR |
| Product Code | KAM |
| Date Received | 2011-04-06 |
| Model Number | 10X40MM |
| Catalog Number | BC1040A |
| Lot Number | 100512B |
| Device Expiration Date | 2012-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-06 |