MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-31 for OLYMPUS BILIARY BALLOON B-230Q-A manufactured by Olympus Medical Systems Corporation.
[20394915]
The device referenced in this report was returned to olympus for evaluation. However, the device was received in a biohazard container with signs of biomaterial on the device, which limited the evaluation to visual inspection. There were multiple kinks noted on the blue sheath of the device, which likely contributed to the reported phenomenon. The reported phenomenon was likely due to physical damage. The balloon will be forwarded to the original equipment manufacturer for further evaluation. If significant additional information becomes available, a supplemental report will follow. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[20412511]
The user facility reported that during a therapeutic endoscopic retrograde pancreatography (ercp) procedure, the balloon became stuck in the patient's common bile duct. The users experienced difficulty deflating the subject balloon after the second or third pass. The users made multiple attempts to deflate the balloon, but with no success. The users tried using different size of syringes to aspirate air from the balloon, but was not successful. The users tried using reusable biliary biopsy forceps, trapezoid basket and needle knife, but with no result. The users removed the scope from the patient, and used a pentax's scope to decompress the patient's stomach and small bowel, and after doing so, the users noted that the balloon was deflating on its own. The procedure was completed, but it was extended for about 30-45 minutes. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2011-00112 |
| MDR Report Key | 2118131 |
| Report Source | 06 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-05-02 |
| Date of Event | 2011-03-01 |
| Date Mfgr Received | 2011-05-02 |
| Date Added to Maude | 2011-08-22 |
| 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 | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 2951 ISHIKAWA-CHO HACHIOJI-SHI |
| Manufacturer City | TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS BILIARY BALLOON |
| Generic Name | BALLOON |
| Product Code | FTJ |
| Date Received | 2011-05-31 |
| Returned To Mfg | 2011-05-23 |
| Model Number | B-230Q-A |
| Lot Number | 12K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-31 |