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 2020-03-26 for EPIC BILIARY M00572330 57233 manufactured by Boston Scientific Corporation.
[185212226]
(b)(4). The returned epic biliary stent was analyzed, and a visual evaluation noted that the stent was received deployed outside the delivery system. The stent was stretched and slightly deformed. Multiple kinks in the inner liner were noted and the sheath was buckled in two separate places. A microscopic examination revealed that the inner liner is prolapsed 14. 1cm from the tip. No other issues with the device were noted. The reported event was confirmed. The analysis of the device found damage that could have contributed to the failure to deploy in the patient. The kinks in the shaft were most likely caused by the handling of the device when it was sent back for analysis. Buckling to the sheath suggests there was difficulty advancing to the lesion. Prolapsing of the inner liner indicates there was difficulty deploying the stent. Tortuosity can potentially cause issues; therefore, it is likely that the patient's anatomy contributed to the resistance which led to the creation of the damages. The damage to the stent likely occurred when the new stent was passed down the working channel. Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to patient condition.
Patient Sequence No: 1, Text Type: N, H10
[185212227]
It was reported to boston scientific corporation that an epic biliary stent was to be implanted to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020. It was reported that the anatomy was dilated prior to the stent placement procedure and the patient had a slightly tortuous anatomy. According to the complainant, during the procedure, the physician lined up the ro marker to deploy the stent in the bile duct; however, the stent fully deployed in the scope. The stent was removed from the scope when another stent was passed down the working channel of the scope. The procedure was completed with a wallflex 10x80 stent. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation finding of stent deformation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01337 |
| MDR Report Key | 9885566 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-17 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | EPIC BILIARY |
| Generic Name | CATHETER, BILIARY, DIAGNOSTIC |
| Product Code | FGE |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-11 |
| Model Number | M00572330 |
| Catalog Number | 57233 |
| Lot Number | 0024614322 |
| 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 | 2020-03-26 |