MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for LIGHTTRAIL SINGLE USE M0068F64520 69267 manufactured by Boston Scientific Corporation.
[185597430]
(b)(6). (b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185597431]
It was reported to boston scientific corporation on march 09, 2020 that a lighttrail single use 365um laser fiber was used in a cistolitotripsia procedure in the bladder performed on (b)(6) 2020. Reportedly, the laser unit used was an auriga 30 watt laser console with laser settings 800 millijoules and 8 hertz. According to the complainant, during the procedure, the laser fiber was broken and a small piece of glass fiber, the tip, fell inside the bladder of the patient. Reportedly, the fiber fragment, the tip, was retrieved successfully using a cystoscope. The procedure was completed with the original device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01384 |
| MDR Report Key | 9897786 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-03-30 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | MODEL FARM ROAD CORK |
| Manufacturer City | CORK IRELAND |
| Manufacturer Country | EI |
| Manufacturer Postal Code | IRELAND |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTTRAIL SINGLE USE |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT |
| Product Code | GEX |
| Date Received | 2020-03-30 |
| Model Number | M0068F64520 |
| Catalog Number | 69267 |
| Lot Number | 0024029028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |