MAUDE Adverse Event Report: COOK ENDOSCOPY HEMOSPRAY ENDOSCOPIC HEMOSTAT

Catalog Number HEMO-10

Device Problems Difficult to Remove (1528); Human-Device Interface Problem (2949); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: common device name: not available, regulation name: hemostatic device for intraluminal gastrointestinal use.Pma/510k: den170015.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: a corrective action has been initiated to address this failure mode.The report indicated the powder temporarily adhered the endoscope to tissue.Overall clinical success was achieved with the use of the hemospray device.Prior to distribution, all hemospray endoscopic hemostats are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.A corrective action has been initiated in an effort to reduce occurrences of this nature.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 esophagogastroduodenoscopy (egd), the physician used a cook hemospray endoscopic hemostat.This was a gastric bleed procedure; the endoscope, with the hemospray, was in a retroflexed position, toward the lesser curvature of the stomach, and the physician propelled the hemospray to try to stop the bleed.The physician then tried to remove the endoscope, but the endoscope was stuck at the gastro-esophageal (ge) junction.The physician's analysis was that because of the curve, the endoscope was hindered from being removed.The hemospray had made a "paste/film/coating" [sic] that appeared to inhibit movement and removal.It was stuck to the mucosa.The physician tried different maneuvers with the endoscope, which were unsuccessful, and then tried to irrigate it with water.The physician was then able to remove the paste/film and was able to remove the endoscope from the patient.No harm was done to the patient." the following additional information was received on 13-feb-2019: the endoscope took five (5) minutes to remove with 100-200 cc of sterile water.The patient was hemodynamically stable and there was slow bleeding from the vascular ectasia [chronic gastrointestinal bleeding].The esophagus had normal diameter with no hiatus hernia.The physician passed a regular endoscope with no problems and used argon plasma coagulation.Later, the physician decided to use hemospray and passed a double-channel gastroscope [down the esophagus] [endoscope changed] with no problems.The gastroscope only became stuck when the physician applied the hemospray powder in a retroflexed position, as the bleeding lesions were along the lesser curve close to the hiatus.Lubricant was applied to the distal end of the endoscope.No pooled blood made contact with the endoscope shaft.Water was not used to flush the inner gastrointestinal tract prior to 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.

• Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 8386669
• MDR Text Key: 141598256
• Report Number: 1037905-2019-00097
• Device Sequence Number: 1
• Product Code: QAU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HEMO-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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