MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2014-08-15 for FUSION BILIARY DILATION CATHETER FS-BDC-10 manufactured by Wilson-cook Medical Inc..
[19086259]
During the procedure, a cook fusion biliary dilation catheter was used. The device was put over a long wire guide. The dilation catheter snapped in half during the procedure. The breakage was approximately 20 cm from the tip. No section of the device detached inside the patient or endoscope. A section of the device did not remain inside the patient's body. 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
[19130792]
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The catheter was returned in two sections. The ends of the both sections were stretched out of shape. The distal section measure 85. 7 cm. The proximal section measures 181 cm. The total measured length is 266. 7 cm, which is longer than the appropriate specification. The catheter was stretched approximately 63 cm. There was damage to the skive and the marker band just distal of the skive. There is a tear in the catheter approximately 5mm long from the distal end of the skive to the marker band just distal of the skive. No part of the device appears to be missing. 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 this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. The instructions for use state, "visually inspect with particular attention to kinks, bends, and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. " and "note: for best results, wire guide should be kept wet. " prior to distribution, all fusion biliary dilation catheters 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 and this represents an isolated occurrence. 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 mark feedback continues to become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037905-2014-00325 |
| MDR Report Key | 4036671 |
| Report Source | 01,05,07,08 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-07-16 |
| Date Facility Aware | 2014-07-16 |
| Report Date | 2014-07-18 |
| Date Mfgr Received | 2014-07-21 |
| Device Manufacturer Date | 2013-02-27 |
| Date Added to Maude | 2014-09-09 |
| 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 | SCOTTIE FARIOLE, MGR. |
| Manufacturer Street | 4900 BETHANIA STATION RD. |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSION BILIARY DILATION CATHETER |
| Generic Name | GCC, DILATOR, CATHETER |
| Product Code | GCC |
| Date Received | 2014-08-15 |
| Returned To Mfg | 2014-08-04 |
| Catalog Number | FS-BDC-10 |
| Lot Number | W3256401 |
| Device Expiration Date | 2016-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 17 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILSON-COOK MEDICAL INC. |
| Manufacturer Address | WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-15 |