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 2019-04-29 for WALLFLEX COLONIC M00565050 6505 manufactured by Boston Scientific Corporation.
[143530827]
The complainant was unable to provide the suspect device lot number. Therefore, the manufacture and expiration dates are unknown. (b)(4). The complainant indicated that the suspect 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 mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143530828]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex colonic stent had been implanted to treat a malignant bowel obstruction in the sigmoid colon during a sigmoidoscopy with stent placement procedure performed on (b)(6) 2019. Reportedly, the patient's anatomy was tortuous. According to the complainant, during the procedure, the stent was deployed; however, the stent migrated proximally. The procedure was stopped and the patient was referred to a different physician. Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in place. On (b)(6) 2019, another wallflex colonic stent was implanted. No patient complications were reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02240 |
| MDR Report Key | 8562546 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-04-29 |
| 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 | 2019-04-29 |
| Model Number | M00565050 |
| Catalog Number | 6505 |
| 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 | 2019-04-29 |