MAUDE Adverse Event Report: COOK ENDOSCOPY HEMOSPRAY ENDOSCOPIC HEMOSTAT

Catalog Number	HEMO-7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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.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 or Problem Description
During an esophagogastroduodenoscopy (egd) hemostasis procedure, the physician used a cook hemospray endoscopic hemostat.The patient underwent a post banding ulcer procedure in the esophagus due to prior varices which had been previously treated.The patient was intubated.The physician banded below the ulcer, injected with medicine and then used the hemospray endoscopic hemostat and sprayed the intended area approximately 20-25 times.The hemospray treated the are well and to the physician's satisfaction.When physician went to remove the endoscope, it was stuck to the esophagus as the hemospray [powder] had gotten onto the end of the endoscope.With some tugging, the endoscope pulled away from the esophagus causing no harm, no tears, no trauma to the esophagus.The physician stated that the device worked as intended and performed really well and was pleased with the procedure outcome.In noting the hemospray had gotten onto the endoscope, the physician stated that some of the hemospray may have gotten into the patient's lungs.The physician kept the patient intubated and overnight for observation.The patient did well and was released the next morning.The following was received (b)(6) 2019: "because of the amount of hemospray used, the distal end of the endoscope was covered with hemospray.When the endoscope was being removed from the patient, this is when some of the hemospray came off in the cricopharyngeal area (where the esophagus & trachea split)." the following was received (b)(6) 2019 directly from the physician involved: ".[the patient was a] (b)(6) y/o hm [hispanic male] with decompensated alcohol associated liver disease who underwent egd with esophageal varices banding (two bands placed in the esophagus) on (b)(6) 2019 for symptoms of melena [black, tarry stool indicative of blood]; patient did fine and was discharged.Patient subsequently re-admitted (b)(6) 2019 for hematemesis [vomiting blood]; patient was in the intensive care unit and was electively intubated prior to procedure by anesthesia given his hematemesis; egd showed two post-banding (esophageal) ulcers with high risk bleeding features; one band was initially placed below the esophageal post-banding ulcers; ethanolamine was injected (submucosa) below each post-banding ulcer (1 cc each site).Subsequently, due to the high risk bleeding features and in the setting of decompensated cirrhosis, approximately 20 hemospray applications were administered to the post-banding (esophageal) ulcer sites.These appeared well treated.Subsequently, i was not able to remove the endoscope.I gently applied pressure to remove it; it took, by estimate, a few minutes to remove the endoscope; the endoscope distal portion (distal estimated 5-7 cm) was covered with hemospray that was hard to remove.The hemospray also appeared to be in his posterior pharynx of a medium/large degree; it was felt safest by the anesthesia provider to keep patient intubated the rest of the day/overnight in order to decrease risk of airway compromise.Patient was extubated the next day without any gastrointestinal bleeding symptoms.He did fine and was discharged 3 days later.Other than the hemospray powder, a section of the device did not remain inside the patient¿s body.The patient remained intubated and hospitalized overnight 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
• MDR Report Key: 9286826
• Report Number: 1037905-2019-00675
• Device Sequence Number: 2147499
• Product Code: QAU
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: HEMO-7
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 59 YR