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 2019-01-10 for WALLFLEX COLONIC M00565040 6504 manufactured by Boston Scientific Corporation.
[132783517]
Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (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
[132783518]
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent was to be used to treat a 4cm malignant stricture in the colon due to colorectal cancer during a lower gastrointestinal stent placement procedure performed on (b)(6) 2018. Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent prematurely deployed and was free floating in the lumen. The stent was removed with forceps and another wallflex colonic stent was placed to complete the procedure. There were no patient complications as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62559 |
| MDR Report Key | 8237608 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-19 |
| Device Manufacturer Date | 2017-07-08 |
| Date Added to Maude | 2019-01-10 |
| 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 | WALLFLEX COLONIC |
| Generic Name | STENT, COLONIC, METALIC, EXPANDABLE |
| Product Code | MQR |
| Date Received | 2019-01-10 |
| Model Number | M00565040 |
| Catalog Number | 6504 |
| Lot Number | 0020859767 |
| Device Expiration Date | 2019-07-08 |
| 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 | 2019-01-10 |