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 2019-02-13 for FUSION QUATTRO EXTRACTION BALLOON FS-QEB-B manufactured by Cook Endoscopy.
[139452667]
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation. The report could not be confirmed. A review of the device history record could not be conducted because the lot number was not provided. Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation. A definitive cause for the reported observation could not be determined. Prior to distribution, all fusion quattro extraction balloons are subjected to a visual and functional test to ensure device integrity. The functional test includes an air inflation test to ensure proper balloon function. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Patient Sequence No: 1, Text Type: N, H10
[139452668]
In preparation for a procedure, the user selected a cook fusion quattro extraction balloon. The balloon would not deflate. Additional information provided on 25-jan-2019: the device did not make patient contact. According to the nurse using the device, she inflated the balloon, and it looked 'funny', had an odd shape, and would not deflate. They opened a second balloon of the same type. This occurred prior to patient contact; there was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00065 |
| MDR Report Key | 8336504 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-23 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-13 |
| 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 | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSION QUATTRO EXTRACTION BALLOON |
| Generic Name | GCA, CATHETER, BILIARY, SURGICAL |
| Product Code | GCA |
| Date Received | 2019-02-13 |
| Catalog Number | FS-QEB-B |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-13 |