MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HEMOSPRAY ENDOSCOPIC HEMOSTAT; HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE

Catalog Number	HEMO-10
Medical Device Problem Codes	Obstruction of Flow (2423); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure to treat a bleeding bulbar ulcer in the stomach, the physician used a cook hemospray endoscopic hemostat.It was reported that the hemospray didn't work.Nothing was released, neither the co2 [carbon dioxide] gas or the powder was released.Another of the same device was used to complete the procedure.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.
Additional Manufacturer Narrative
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in a clear plastic bag and an open tray from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.All components were included in the return.Both catheters were included in the return and appear to be unused.The device was returned with the on/off switch in the "off" position.The red activation knob was engaged in the handle indicating activation of the carbon dioxide (co2) cartridge.Loose powder was not present within the tray or on any of the returned components.When tested as returned the device did not spray as intended.The co2 cartridge did not audibly discharge upon deactivation and the cartridge was fully punctured.A visual examination of the o-ring and lance inside the handle showed both components to be positioned correctly inside the handle and the lance to be beveled.The inspection of the co2 cartridge and regulator (lance and o-ring) confirm the device was of the current design.The foam was present and in the correct orientation (slits facing the red activation knob).When tested with a new co2 cartridge and activation knob, the device began spraying nonstop, without pressing the red button, immediately when the switch was turned to the "on" position.The handle was disassembled, and the tubes were disconnected for removal of any powder.Loose powder was present in the front tube connecting the on/off valve to the powder chamber.Loose powder was also present in the back tube connecting the powder chamber to the low pressure valve.No clumps were found in either tube.A visual inspection of the hole in the bottom of the powder chamber showed it to be clear.Loose powder was removed from the smaller powder cannula.The low pressure valve was disassembled and evaluated.All the internal components were intact.However, powder was observed within the low pressure valve on all the components.This is the most likely cause resulting in the valve remaining open due to the powder.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 conclusion: our laboratory evaluation of the product said to be involved confirmed the report.The root cause for report of unable to spray was an internal clog within the low pressure valve of the device.The cause of the clog is unknown.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.It was noted that the returned catheters appear to be unused indicating this device may have been used with a different catheter which was not provided in the return.Catheter occlusion can be a cause of this device not being able to spray powder or result in internal clogs within the device.However, we could not conduct a complete investigation because the used catheter was not returned for evaluation.This limits our ability to conclusively determine a cause.The user did not occlude the red hub of the catheter during advancement.The ifu states: "to limit fluid from entering the working channel of the catheter, temporarily occlude the proximal end of the catheter by placing a thumb over the red hub, while advancing the catheter down the accessory channel." a corrective action (capa) was initiated to further investigate device failure due to being unable to spray powder.This device is within the scope of the capa.Prior to distribution, all hemospray endoscopic hemostats are subjected to a visual inspection 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.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: HEMOSPRAY ENDOSCOPIC HEMOSTAT
• Common Device Name: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON COOK MEDICAL INC.; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 8002454707
• MDR Report Key: 19345835
• Report Number: 1037905-2024-00271
• Device Sequence Number: 17772096
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)250901(10)W4632816
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Catalogue Number: HEMO-10
• Device Lot Number: W4632816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX ENDOSCOPE - UNKNOWN MODEL NUMBER
• Patient Sex: Unknown