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 2019-01-10 for WALLFLEX COLONIC M00565040 6504 manufactured by Boston Scientific Corporation.
[132784317]
(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 medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132784318]
Note: this report pertains to one of the two devices used during the same procedure. Refer to manufacturer report # 3005099803-2019-00053 for the associated device information. It was reported to boston scientific corporation on (b)(6) 2018 that two wallflex colonic stents were used during a colonic stenting procedure performed on (b)(6) 2018. Reportedly, the patient's anatomy was tortuous and the was not dilated prior to stent placement. According to the complainant, during the procedure, the first wallflex colonic stent (the subject of this report) was "not attached to the lesion", and the delivery system was difficult to remove. Reportedly, the stent came out along with the delivery system during catheter removal. A second wallflex colonic stent ( the subject of mfr. Report # 3005099803-2019-00053) was used but the same thing occurred. The procedure was completed with another wallflex colonic stent. There were no patient complications reported as a result of this event. Note: a photo of the complaint device showed a fully deployed stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-00052 |
| MDR Report Key | 8237287 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-12-16 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2017-08-18 |
| 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 |
| Returned To Mfg | 2019-01-10 |
| Model Number | M00565040 |
| Catalog Number | 6504 |
| Lot Number | 0021015848 |
| Device Expiration Date | 2019-08-16 |
| 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 | 2019-01-10 |