MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION QUATTRO EXTRACTION BALLOON; GCA, CATHETER, BILIARY, SURGICAL

Catalog Number FS-QEB-A

Device Problem Burst Container or Vessel (1074)

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.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.

• 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 Key: 4976308
• MDR Text Key: 15243934
• Report Number: 1037905-2015-00330
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,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 Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FS-QEB-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• 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