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 2019-03-04 for FUSION QUATTRO EXTRACTION BALLOON FS-QEB-A manufactured by Cook Endoscopy.
[141340799]
Occupation: non-healthcare professional. Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. A visual inspection of the returned device determined that the balloon material was ruptured. Most of the balloon material is missing and not all of the ruptured material matches up from side to side. Due to the condition of the balloon material a functional test could not be performed. The threads on the proximal and distal end of the balloon appear to be manufactured correctly. The pre-packaged syringe was included in the return. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation. A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product. The information provided indicated the balloon inflated properly prior to use. Therefore, the balloon was intact and functioning prior to advancement through the endoscope. A split or rupture in the balloon material can occur if the balloon has come into contact with a sharp object, such as a sharp stone, or possibly a burr in the endoscope channel. Prior to distribution, all fusion quattro extraction balloons are subjected to a visual inspection and functional testing to ensure device integrity. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. 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
[141340800]
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon. Upon extracting stones from the bile duct, the balloon snapped (ruptured). There was no reportable information at this time. The device was received for evaluation on (b)(6) 2019. Our evaluation of the returned device determined that there were pieces of the balloon material missing and were not included in the return of the device. This information was communicated to the user facility and the location of the missing pieces was unknown. The initial reporter stated that a section of the device did not remain inside the patient? S body; however the location of the missing section detected during our laboratory evaluation is unknown. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2019-00104 |
| MDR Report Key | 8388130 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-04 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2018-09-19 |
| Date Added to Maude | 2019-03-04 |
| 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 | 2019-03-04 |
| Returned To Mfg | 2019-02-07 |
| Catalog Number | FS-QEB-A |
| Lot Number | W4117928 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-04 |