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 2019-05-14 for WALLFLEX COLONIC M00565050 6505 manufactured by Boston Scientific Corporation.
[145011494]
(b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145011495]
It was reported to boston scientfic corporation on (b)(6) 2019 that a wallflex colonic stent was implanted during a colonosocpy with stent placement procedure performed on (b)(6) 2019 as a bridge to surgery for a 4 cm malignant stricture in the colon. Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement procedure. According to the complainant, during the procedure, the stent was prematurely deployed proximally beyond the stricture. The stent remains implanted and a second stent was placed to complete the procedure. Reportedly, the physician is comfortable leaving the stent in place as both stents will be explanted in about a month. There were no patient complications reported asa 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 | 3005099803-2019-02529 |
| MDR Report Key | 8608910 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-04-23 |
| Device Manufacturer Date | 2017-11-08 |
| Date Added to Maude | 2019-05-14 |
| 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 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 | 2019-05-14 |
| Model Number | M00565050 |
| Catalog Number | 6505 |
| Lot Number | 0021359210 |
| Device Expiration Date | 2019-11-08 |
| 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 | 2019-05-14 |