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 2018-03-29 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903100 390-310 manufactured by Boston Scientific - Marlborough.
[103827146]
(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
[103827147]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney during an unknown procedure on an unknown date. According to the complainant, during the procedure, a 270 micron laser fiber was used to fragment a stone positioned under the coil. However, the distal portion of the coil broke off and migrated to the lower calyx of the left kidney making visualization of the broken portion difficult. The broken portion of the cone eventually migrated to the left iliolumbar ureter and another urethroscopy for extraction was performed. A month after the procedure, during follow-up visit, a kidney scan was performed and a foreign body was found in the kidney. On (b)(6) 2018, a procedure was performed to remove the piece of the stone cone from the patient? S kidney. 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? No problem?. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00943 |
| MDR Report Key | 7381660 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-05-04 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2018-03-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL |
| Generic Name | DISLODGER, STONE, FLEXIBLE |
| Product Code | FGO |
| Date Received | 2018-03-29 |
| Returned To Mfg | 2018-03-29 |
| Model Number | M0063903100 |
| Catalog Number | 390-310 |
| Lot Number | 0003768067 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-03-29 |