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 2019-01-08 for OCCLUDER M0062201070 220107 manufactured by Boston Scientific Corporation.
[132412912]
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown. (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132412913]
It was reported to boston scientific corporation that an occluder balloon catheter was used during a ureteroscopic stone retrieval procedure performed on (b)(6) 2016. On (b)(6) 2016, the patient underwent a ureteroscopic stone retrieval procedure and the occluder tube was left inside the patient when she was discharged on (b)(6) 2018 due to ureteric obstruction. Whilst recovering at home, it was noticed that the tube was draining less. By (b)(6) 2016 the device had completely stopped draining. The patient attended a&e on (b)(6) 2016 with pain and a fever. The patient was then admitted to the hospital and a nephrostogram was performed on (b)(6) 2016. This showed that the device had fractured. The tube remained in the kidney but was not connected to the drainage bag. The tube was removed via laparoscopy the same day. It was replaced with a new tube that drained well. The patient was discharged home and a good recovery was made, with the tube being removed on (b)(6) 2016. The patient current condition and prognosis is under investigation. The patient continues to suffer with back pain and has significant scarring from the need for a further operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62433 |
| MDR Report Key | 8226072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2019-01-08 |
| 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 CORK LIMITED |
| Manufacturer Street | CORK BUSINESS TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCCLUDER |
| Generic Name | CATHETER, UROLOGICAL |
| Product Code | EYB |
| Date Received | 2019-01-08 |
| Model Number | M0062201070 |
| Catalog Number | 220107 |
| 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 | 1. Required No Informationntervention | 2019-01-08 |