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 2019-04-12 for WALLFLEX COLONIC M00565040 6504 manufactured by Boston Scientific Corporation.
[141771598]
Age or date of birth: patient's exact age is unknown; however it was reported that the patient was over the age of 18. (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
[141771599]
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex colonic stent was implanted in the sigmoid colon to treat a 6-7 cm mass during a colonoscopy with 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, it was difficult to unsheathe the stent. The stent suddenly deployed through the stricture and moved to the proximal part of the colon. A longer wallflex colonic stent was placed stent-in-stent within the initial stent to complete the procedure. There were no patient complications as a result of this event. The patient's condition at the conclusion of the procedure was reported to be good with passing gas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-01745 |
| MDR Report Key | 8509485 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2019-02-04 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| Model Number | M00565040 |
| Catalog Number | 6504 |
| Lot Number | 0023279444 |
| 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 | 2019-04-12 |