MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-14 for ZERO TIP M0063901050 390-105 manufactured by Boston Scientific Corporation.
[179405666]
Medwatch #: mw5091277. Patient identifier: (b)(6). Patient weight: (b)(6) kg. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179405667]
It was reported to boston scientific corporation that a zero tip stone retrieval basket was used during a ureteroscopy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the basket was gently pulled on with constant pressure but the middle of the shaft broke into the upper ureter. The stone was unable to be released from the basket, and an attempt to retrieve with a grasper was unsuccessful. Two basket wires were then lasered in order to release the stone. The patient needed two additional procedures to remove the retained basket wires. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00439 |
| MDR Report Key | 9710834 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-10-25 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-14 |
| 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 CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZERO TIP |
| Generic Name | DISLODGER, STONE, BASKET, URETERAL, METAL |
| Product Code | FFL |
| Date Received | 2020-02-14 |
| Model Number | M0063901050 |
| Catalog Number | 390-105 |
| 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 | 2020-02-14 |