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 2020-01-08 for RIGIFLEX II M00554510 5451 manufactured by Boston Scientific Corporation.
[174152564]
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[174152565]
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during an esophagogastroduodenoscopy (edg) with dilatation procedure performed on (b)(6) 2019. According to the complainant, after the dilatation, it was noted that the esophagus had been perforated. The patient was then transferred to (b)(6) where an emergent surgery was performed by a cardio-thoracic surgeon. Following the treatment, the patient condition was reported to be stable. It was noted that there was no malfunction of the rigiflex ii dilatation balloon, and per the physician's assessment, the cause of the perforation was the anatomy. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06443 |
| MDR Report Key | 9564068 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-01-08 |
| 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 | TECHDEVICE CORPORATION |
| Manufacturer Street | 400M ESTE DE HOLCIM |
| Manufacturer City | SAN RAFAEL ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIGIFLEX II |
| Generic Name | DILATOR, ESOPHAGEAL |
| Product Code | PID |
| Date Received | 2020-01-08 |
| Model Number | M00554510 |
| Catalog Number | 5451 |
| Lot Number | C021175 |
| 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 | 2020-01-08 |