MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-16 for STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL UNK275 manufactured by Boston Scientific - Marlborough.
[82816204]
The physician indicated that the procedure occurred in (b)(6) 2017, with no exact date. The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown. However, the complainant stated that the device was used prior to the expiration date. (b)(4). The complainant indicated that the device has been 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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[82816205]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the mid-ureter during a cystoscopy, ureteroscopy and laser lithotripsy procedure on (b)(6) 2017. The exact day of the procedure was not provided. According to the complainant, during the procedure, a portion of the stone cone broke off during the procedure, and migrated proximally into the kidney. After the procedure, the physician felt a high index of suspicion, retrieved the stone cone device from the trash and examined the device. It was discovered to be missing a portion. The patient was returned to the operating room, and had the piece removed. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02558 |
| MDR Report Key | 6798106 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-16 |
| Date of Report | 2017-07-20 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-08-16 |
| 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 | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | LAKE REGION MANUFACTURING |
| Manufacturer Street | 340 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE NITINOL UTROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2017-08-16 |
| Model Number | UNK275 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-16 |