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 2020-03-25 for MAXFORCE M00567380 6738 manufactured by Boston Scientific Corporation.
[185201747]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). Investigation results: a visual examination of the returned complaint device found that the balloon burst. No damage found on the catheter of the device. Functional evaluation could not be performed due to the condition of the returned device. This failure is likely due to factors encountered during the procedure, such as the manner the device was handled or manipulated, the technique used by the physician during the procedure, the amount of strength applied by the customer during the movement of the balloon, and/or the interaction between the scope and the balloon could have resulted in the damage found on the balloon. Therefore, the most probable root cause is adverse event related to procedure. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications. A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Patient Sequence No: 1, Text Type: N, H10
[185201748]
It was reported to boston scientific corporation that a maxforce biliary dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, a leak was noted on the balloon. The procedure was completed with another maxforce biliary dilatation balloon. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be good. Investigation results revealed that the balloon was ruptured; therefore, this is now an mdr reportable event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01215 |
| MDR Report Key | 9881072 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-04-10 |
| Date Added to Maude | 2020-03-25 |
| 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 IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXFORCE |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-01-31 |
| Model Number | M00567380 |
| Catalog Number | 6738 |
| Lot Number | 0023624912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-25 |