MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-10 for STANDARD BALL00N CATHETER,SILICONE (6/PK) 890923 manufactured by Gyrus Acmi, Inc.
[132641127]
The device has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Despite several followup attempts, there is no further information regarding the sequence of events leading to the bursting, whether the device was inspected before use, patient pre-existing conditions, or the current patient status. As a preventive measure against device malfunction, the device instruction for use document cautions? Inspect all packages for punctures or evidence of contamination prior to opening.? As a general precaution against patient injury, the instruction for use document also states that the patient tissue should be regularly inspected while the inflated device is in use due to potential pressure necrosis.
Patient Sequence No: 1, Text Type: N, H10
[132641128]
3 of 3. Olympus was informed that during a during a sinus septoplasty procedure, the balloon portion of the device burst while in the patient. The patient was transported to the hospital to complete the procedure. There is currently no further information on the patient condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00347 |
| MDR Report Key | 8234409 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2018-12-17 |
| Date Added to Maude | 2019-01-10 |
| 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 | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD BALL00N CATHETER,SILICONE (6/PK) |
| Generic Name | BALLOON, EPISTAXIS |
| Product Code | EMX |
| Date Received | 2019-01-10 |
| Model Number | 890923 |
| Lot Number | MH807753 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-10 |