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 Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Four sealed devices from the lot number provided in the report and one sealed device from a different lot number but the same rpn were also provided in the return.Device #1, used: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with a kink/bend at 11.4cm from the distal tip and the balloon was ruptured.Under magnification it was noted that not all the sections of the rupture balloon match up, it is possible a portion of the balloon detached.When water was attempted to be injected into the injection port, it could not be injected.Device #2 - #6 (#3 from the different lot #), sealed: our evaluation of the sealed devices could not confirm the report as it was described, the devices functioned as intended.During a function test the balloon was inflated with air using the syringe provided and submerged into water.During inflation the balloon held pressure with no sign of leaks.The balloon was left inflated for 5 minutes with no leaks observed.The devices were injected with water into the injection port and water was able to exit the distal end of the catheter without any difficulties.No anomalies were detected with this device.The device history record for the lot number said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: device #1, used: our evaluation of the device confirmed the report.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.Device #2 - #6 (#3 from the different lot #), sealed: a definitive cause for the reported observation could not be determined because the devices functioned as intended.The information provided did not state if the balloon inflated properly prior to use.The ifu states: "verify the balloon integrity prior to use by attaching the enclosed premeasured syringe to the stopcock and inflating the balloon with air only." a pinhole, split, or rupture in the balloon can occur if the balloon material has come into contact with a sharp object, such as a sharp stone or possibly a burr in the endoscope channel.A pinhole, 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 contain 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 tri-ex extraction balloon with multiple sizing are subjected to a visual and functional test 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: 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.

Event Description

During an unknown endoscopic procedure, the physician used a cook fusion extraction balloon with multiple sizing.It was reported [that the] balloon burst.It is unknown if the balloon burst during testing or in the patient.There was no reportable information at this time.Our evaluation of the returned device received on (b)(6) determined that the balloon was ruptured.It was noted that there were portions of the balloon missing and all sections of the balloon did not match up.[subject of report] it was reported that a section of the device did not remain inside the patient¿s body; the location of the detached balloon material is unknown.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Four sealed devices from the lot number provided in the report and one sealed device from a different lot number but the same rpn were also provided in the return.Device #1, used: our laboratory evaluation of the product said to be involved confirmed the report.The device returned with a kink/bend at 11.4cm from the distal tip and the balloon was ruptured.Under magnification it was noted that not all the sections of the rupture balloon match up, it is possible a portion of the balloon detached.When water was attempted to be injected into the injection port, it could not be injected.Device #2 - #6 (#3 from the different lot #), sealed: our evaluation of the sealed devices could not confirm the report as it was described, the devices functioned as intended.During a function test the balloon was inflated with air using the syringe provided and submerged into water.During inflation the balloon held pressure with no sign of leaks.The balloon was left inflated for 5 minutes with no leaks observed.The devices were injected with water into the injection port and water was able to exit the distal end of the catheter without any difficulties.No anomalies were detected with this device.The device history record for the lot number said to be involved was reviewed.Nonconformances that could potentially be related to the complaint were contained in the associated dhr.The nonconformance documentation supports the affected device(s) were dispositioned appropriately prior to release of this lot.There is no evidence nonconforming product was released for distribution.In an effort to heighten awareness of the potential connection of the customers report to the current manufacturing processes production personnel were notified.Investigation conclusion: device #1, used: our evaluation of the device confirmed the report.Our investigation of the returned device did not identify a cause for the balloon rupture.Device #2 - #6 (#3 from the different lot #), sealed: a definitive cause for the reported observation could not be determined because the devices functioned as intended.In the report it was stated the balloon was tested prior to advancing down the endoscope accessory channel and inflated properly and burst partly during test.Prior to distribution, all tri-ex extraction balloon with multiple sizing are subjected to a visual and functional test 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: 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; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16646441
• MDR Text Key: 313437214
• Report Number: 1037905-2023-00147
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 10827002315379
• UDI-Public: (01)10827002315379(17)230909(10)W4635243
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Catalogue Number: FS-8.5-12-15-A
• Device Lot Number: W4635243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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 - OLYMPUS 190 SERIES