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 2020-01-31 for WALLFLEX COLONIC M00565120 6512 manufactured by Boston Scientific Corporation.
[177399217]
Patient's exact weight is unknown; however it was reported that the patient's body mass index is 27. 68 kg/m2. (b)(4). The complainant indicated that the fragment was disposed of and the stent 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
[177399218]
It was reported to boston scientific corporation on january 10, 2020 that a wallflex colonic stent has been implanted in the colon to treat an extrinsic severe stenosis measuring 1 cm in length x 7 mm in diameter located at 30 cm proximal to the anus during a gastrointestinal stent placement procedure performed on (b)(6) 2019. According to the complainant, post stent placement, the physician noticed that a part of the delivery catheter was sheared off and was left inside the stent lumen. The fragment was successfully removed with biopsy forceps and the stent remains implanted. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00220 |
| MDR Report Key | 9656112 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2018-10-09 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | WALLFLEX COLONIC |
| Generic Name | STENT, COLONIC, METALIC, EXPANDABLE |
| Product Code | MQR |
| Date Received | 2020-01-31 |
| Model Number | M00565120 |
| Catalog Number | 6512 |
| Lot Number | 0022766941 |
| 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 | 2020-01-31 |