MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION QUATTRO EXTRACTION BALLOON; CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-A

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)

Event Date 03/23/2015

Event Type  Injury  

Event Description

During an endoscopy procedure, the physician used a cook fusion quattro extraction balloon.A sharp corner was formed on the ide [intraductal ductal exchange] port of the fusion quattro extraction balloon.The preloaded wire guide in the sphincterotome got damaged by the exchange balloon.When the user removed the wire guide and fusion quattro extraction balloon, bleeding occurred because of a perforation in the ductus choledochus, believed to be caused by the sharp edge of the ide port on the fusion quattro extraction balloon.The physician placed an olympus plastic stent to cover the perforation in the ductus choledochus.A section of the device did not remain inside the pt's body.Other than placing a plastic stent for the perforation, the pt did not require add'l procedures due to this occurrence.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation eval: our eval of the returned device confirmed the report.There is some damage of the adhesive at the balloon joint.Some small sections, less than 1 mm, of adhesive at the balloon joint are missing.The wire guide intraductal exchange (ide) port is damaged.The distal end of the ide port is pull outward approx 1 mm.There are scratches in the catheter around the ide port.The wire guide returned with the extraction balloon has exposed wire spots, less than 1 mm.In addition, fraying of the wire guide was observed at approx 20 cm from the distal end.There is also a bend in the wire guide 3 cm from the distal end.The balloon would inflate and deflate as intended.A product-specific discrepancy that could have caused or contributed to this observation 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 conclusions: 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 pt 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." prior to distribution, all cook fusion quattro extraction balloon 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 mfg 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 market feedback continues to become available.

• Brand Name: FUSION QUATTRO EXTRACTION BALLOON
• Type of Device: CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr, regulatory ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4734289
• MDR Text Key: 5827208
• Report Number: 1037905-2015-00162
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• PMA/PMN Number: K063677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2016
• Device Catalogue Number: FS-QEB-A
• Device Lot Number: W3517851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2015
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF-Q180V ENDOSCOPE; FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; (FS-OMNI-35-260)
• Patient Outcome(s): Required Intervention