MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-19 for OLYMPUS SINGLE USE 3-LUMEN BALLOON CATHETER B-230Q-A NA manufactured by Olympus Medical Systems Corp.
[1483295]
The user facility reported that during a therapeutic endoscopic retrograde cholangiopancreatography, the users could not retrieve a stone, as the tube sheath of the balloon stretched while the balloon was being withdrawn through a non-olympus endoscope. The users reported to have utilized a total of 4 similar balloons, but the same phenomenon recurred. The users then reportedly used a non-olympus balloon to retrieve the stone and complete the procedure. There was no pt injury reported, but the procedure was said to have been significantly prolonged due to the alleged difficulty.
Patient Sequence No: 1, Text Type: D, B5
[8663537]
Additional lot #: 8zk. One balloon from each lot number used in the reported event was returned to olympus for evaluation. The evaluation confirmed that both balloons had stretched tube sheaths. Both balloons were found to have a kink at the distal end of the tube sheath. The kink was consistent with the tube sheath having become lodged in the forceps elevator of the endoscope, likely causing or contributing to the reported phenomenon. The balloons were tested and both balloons inflated, but resistance was noted due to the damaged tube sheath. The cause of the reported phenomenon was determined to be due to physical damage. The balloons were forwarded to the original equipment mfr for further evaluation. If significant additional info becomes available, a supplemental report will be provided. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2010-00053 |
| MDR Report Key | 1637441 |
| Report Source | 05,06 |
| Date Received | 2010-03-19 |
| Date of Report | 2010-02-24 |
| Date of Event | 2010-02-01 |
| Date Mfgr Received | 2010-02-24 |
| Date Added to Maude | 2010-09-28 |
| 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 CORP |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI 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 SINGLE USE 3-LUMEN BALLOON CATHETER |
| Generic Name | BALLOON CATHETER |
| Product Code | FTJ |
| Date Received | 2010-03-19 |
| Returned To Mfg | 2010-03-02 |
| Model Number | B-230Q-A |
| Catalog Number | NA |
| Lot Number | 97K |
| ID Number | NA |
| 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 CORP |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-19 |