MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING; GCA,CATHETER, BILIARY, SURGICAL

Catalog Number FS-8.5-12-15-A

Device Problems Burst Container or Vessel (1074); Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2015

Event Type  Injury  

Event Description

During an endoscopy procedure, the physician used a cook fusion extraction balloon with multiple sizing.The physician was using an extraction balloon which burst.On removing the extraction balloon, the tip of the balloon was broken off and left in the patient's common bile duct (cbd).The physician tried to remove the detached tip by using another balloon behind it, a basket and finally applying suction with a syringe.Unfortunately all were unsuccessful.The physician has spoken to the patient and explained this [event].The physician arranged an x-ray in a week or so to check to see if it has moved.The tip of the balloon remained inside the patient's body.The patient may require an additional procedure due to this occurrence.The patient will be coming back for an x-ray and may require another procedure to remove the detached balloon tip.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our evaluation of a returned device confirmed the report.The distal 3 cm of the device was detached and was not included in the return.The detached section includes the balloon attached to the catheter and three (3) metallic bands.The intra ductal exchange (ide) port to the tip of the remaining catheter on the distal end is damaged and the outer wall of the wire guide lumen is peeled through.The damage to the ide port and catheter wall appears to be from a wire guide.Attempts to recreate this failure using "typical" various wire guide exchange techniques were unsuccessful.Extreme force beyond normal use would be required to cause this type of damage to the device.The portion of the catheter proximal to the ide port showed no damage or distortion.As the balloon portion of the device was not returned the allegation of the balloon rupture could not be investigated.A product-specific discrepancy that could have caused or contributed to this observation was not observed during out 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 patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our lab analysis.This limits our ability to conclusively determine a cause.The returned portion of the device showed evidence of extreme force applied to cause the distal portion of the catheter to break and detach.The cause of the extreme force is unk but is the most likely root cause for the catheter portion of the device detaching.A split or rupture in the balloon material can occur if the balloon was inflated in excess of the recommended inflation volume.The instructions for use direct the user to attach the enclosed syringe to the stopcock (which is attached to the inflation port) to inflate the balloon.A split or rupture in the balloon material can also occur if added pressure was applied during extraction.The instructions for use direct the user to gently withdraw the inflated balloon toward the papilla.The instructions for use contains the following warning: "do not exert excessive pressure on ampulla while extracting stones.If stone does not pass easily, reassess need for sphincterotomy".Prior to distribution, all fusion extraction balloon with multiple sizing 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.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 market feedback continues to become available.

• Brand Name: FUSION EXTRACTION BALLOON WITH MULTIPLE SIZING
• Type of Device: GCA,CATHETER, BILIARY, SURGICAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4810439
• MDR Text Key: 5921085
• Report Number: 1037905-2015-00214
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2016
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W3532265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• 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: ENDOSCOPE (UNK TYPE),
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR