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 2019-04-01 for FASCIAL DILATOR 38975 manufactured by Boston Scientific Corporation.
[140524610]
Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10
[140524611]
It was reported that the patient was experiencing intense pain. A target lesion was located at kidney. Td/8/38 (bx/10) fascial dilator was selected for use. During the procedure, cons old stent was removed when exchanging of a uretic stent and replaced with new expel stent, it was pushed further into the kidney with the pusher. When the dr. Attempted to remove the pusher, it got stuck on the tip of the stent. The device was removed and pulled the whole stent system from the body. Then, the second stent was being inserted. Subsequently, the patient was experiencing great pain without sedation and the procedure went from two to four hours. No further patient complications were reported. Patient condition was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-03238 |
| MDR Report Key | 8470351 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-01 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-05-15 |
| Date Added to Maude | 2019-04-01 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASCIAL DILATOR |
| Generic Name | DILATOR, CATHETER |
| Product Code | GCC |
| Date Received | 2019-04-01 |
| Model Number | 38975 |
| Catalog Number | 38975 |
| Lot Number | 0011231753 |
| Device Expiration Date | 2010-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-01 |