MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-09-30 for RELIEVA INSPIRA AIR 18X40MM BALLOON CATHETER BC1840A manufactured by .
[2347872]
Acclarent was made aware of an event on (b)(6) 2011, for an event involving an 18x40mm inspira air device noted to have difficulty deflating. No pt injury was applicable. The device was returned to acclarent for evaluation on (b)(6) 2011. Follow up with the acting physician was performed on (b)(6) 2011. The device was noted to have been pulled with force upon two inflations to create stabilization of the balloon position. Upon the third inflation, stretching of the shaft occurred from excessive force, resulting in deflation difficulty and separation of the balloon catheter. The remaining portion was grasped with cup and alligator forceps and was able to be removed providing a safe airway. The pt did well with no sequelae.
Patient Sequence No: 1, Text Type: D, B5
[9360352]
Device evaluation confirmed that the device was stretched to the point of separation. No missing parts of the balloon catheter were noted. Based on the info provided, acclarent believes the inspira air device performed as intended in the first and second dilations. The excessive tension used to maintain the balloon position in the third dilation is suspected to have stretched the balloon shaft, eventually disrupting the balloon's ability to properly deflate. A manufacturing review was conducting and no abnormalities were noted. No negative trends were identified from a review of the complaint database. Acclarent's ifu's warnings and precautions states to never advance or retract the devices against resistance as this could cause device damage. Acclarent will continue to update the file with any additional info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2011-00009 |
| MDR Report Key | 2278784 |
| Report Source | 07 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-28 |
| Date of Event | 2011-09-01 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2012-07-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DRIVE |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA INSPIRA AIR 18X40MM BALLOON CATHETER |
| Generic Name | INSPIRA AIR |
| Product Code | KAM |
| Date Received | 2011-09-30 |
| Model Number | 18X40MM |
| Catalog Number | BC1840A |
| Lot Number | 110506B |
| Device Expiration Date | 2013-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-30 |