Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL Back to Search Results
Catalog Number FS-QEB-A
Device Problems Burst Container or Vessel (1074); Material Protrusion/Extrusion (2979)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Event Date 07/15/2015
Event Type  Injury  
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.The extraction balloon broke during the first trawl [sweep] of the duct.The physician stated that he did not exert any unusual pressure on the balloon during these procedure.A new balloon was required to be opened to complete the procedure.
 
Manufacturer Narrative
Initially, the following information was provided to cook: during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.The extraction balloon broke during the first trawl [sweep] of the duct.The physician stated that he did not exert any unusual pressure on the balloon during these procedure.A new balloon was required to be opened to complete the procedure.A section of the device did not remain inside the patient¿s body, other than removing the device portion through the endoscope in the initial procedure.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.An initial mdr was submitted on 8/5/2015 based on this information.The following clarification was received on 8/6/2015: the balloon split [rupture] while trawling [sweeping] the biliary duct.There was not any product retained by the endoscope.The broken [ruptured] balloon was removed through the channel of the endoscope and a new one opened.There was no part of device that detached during the procedure.The balloon just seemed to split [rupture].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.Based on this information, this incident no longer meets the reporting criteria of a fda mdr report.
 
Event Description
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.
 
Manufacturer Narrative
On 8/5/2015, an initial mdr report was submitted.Based on the information received at that time we believed the event to be considered a reportable event.On 8/6/2015, clarification was received that determined a non reportable event had occurred.On 9/1/2015, the device returned to cook for evaluation.Our evaluation determined the ide port was damaged.Ide port damage is considered a reportable event.
 
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion quattro extraction balloon.The extraction balloon broke during the first trawl [sweep] of the duct.The physician stated that he did not exert any unusual pressure on the balloon during these procedure.A new balloon was required to be opened to complete the procedure.The following clarification was received on 8/6/2015: the balloon split [rupture] while trawling [sweeping] the biliary duct.There was not any product retained by the endoscope.The broken [ruptured] balloon was removed through the channel of the endoscope and a new one opened.There was no part of device that detached during the procedure.The balloon just seemed to split [rupture].Based on this information, this incident no longer met the reporting criteria of a fda mdr report.On 9/1/2015, the device returned to cook for evaluation.Our evaluation determined the intra ductal exchange (ide) port is damaged.Ide port damage is considered a reportable event.
 
Manufacturer Narrative
On 9/8/2015, we became aware that the information provided in the other remarks section was not submitted on the initial emdr.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The balloon material was ruptured.A visual examination found the intra ductal exchange (ide) port damaged.There is a slight kink on the proximal end above the balloon and above the ide port on the proximal end of the device where excessive force could have been applied.The overall length of the device was measured and is within the specified length.A dimensional analysis of the ide port confirmed damage.The ide port is stretched toward the distal end.The ide port is damaged along the wall of the port.The ide port dimension are 7.1 mm and located 8.7 cm from the distal end.A functional verification was performed using the device to simulate an exchange via the ide port.The duodenoscope has an accessory channel that is 4.2 mm in diameter (model number olympus tjf-160v).Using a.035" tracer hybrid wire guide, a wire guide exchange was simulated.During the exchange the wire guide remained in the simulated biliary duct and access was maintained.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 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 laboratory analysis.This limits our ability to conclusively determine a cause.A possible cause of the damage exhibited at the ide port suggests excessive force was applied which could contribute to difficulties during an exchange.The instructions for use direct the user to advance the deflated balloon in short increments through the accessory channel until it is visualized exiting the endoscope.This activity will aid in device preservation.If the elevator of the endoscope is placed in the closed position with the extraction balloon catheter inside the accessory channel, this can contribute to damage to the catheter.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.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FUSION QUATTRO EXTRACTION BALLOON
Type of Device
GCA, CATHETER, BILIARY, SURGICAL
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key4974668
MDR Text Key6080412
Report Number1037905-2015-00329
Device Sequence Number1
Product Code GCA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K063677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor,company represent
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFS-QEB-A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/15/2015
Device Age9 MO
Event Location Hospital
Date Manufacturer Received09/08/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-