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 2019-02-01 for WALLFLEX COLONIC M00565050 6505 manufactured by Boston Scientific Corporation.
[134749568]
(b)(4). The device has not been received for analysis. Upon receipt and 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
[134749569]
It was reported to boston scientific corporation on january 08, 2019 that a wallflex colonic stent was to be used to treat a malignant stenosis in the intestinal tract during a stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement. According to the complainant, during the procedure, the stent was halfway deployed when viewed under the x-ray. Reportedly, after some manipulation, the stent was deployed all of a sudden inside the mass. The stent was removed with snares and another wallflex colonic stent was placed to complete the procedure. There were no patient complications reported as a result of this event. The patient's condition following the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00274 |
| MDR Report Key | 8297443 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-01 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2018-01-18 |
| Date Added to Maude | 2019-02-01 |
| 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 | 2019-02-01 |
| Returned To Mfg | 2019-01-29 |
| Model Number | M00565050 |
| Catalog Number | 6505 |
| Lot Number | 0021626621 |
| 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 CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-01 |