MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-07-21 for STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL M0063903100 390-310 manufactured by Boston Scientific - Marlborough.
[80620175]
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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
[80620176]
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter on a procedure performed on (b)(6) 2017. According to the complainant, during the procedure, the stone cone retrieval device failed to retract into the sheath. The retrieval device was removed together with the scope from the patient's body. However, when the device was removed it was found the tip broke and detached. A grasping forceps was used to retrieved the detached tip. Fluoroscopy confirmed that no device fragments are left inside the patient. Additionally, it was reported that a laser was used during the procedure but it did not damage the retrieval device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-02080 |
| MDR Report Key | 6731037 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-07-21 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2016-08-08 |
| Date Added to Maude | 2017-07-21 |
| 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 | ACCELLENT ENDOSCOPY JUAREZ |
| Manufacturer Street | 31C BUTTERFIELD TRAIL |
| Manufacturer City | EL PASO TX 79906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 79906 |
| 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 | 2017-07-21 |
| Returned To Mfg | 2017-06-28 |
| Model Number | M0063903100 |
| Catalog Number | 390-310 |
| Lot Number | F52633 |
| Device Expiration Date | 2019-06-09 |
| 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. Required No Informationntervention | 2017-07-21 |