MAUDE Adverse Event Report: COOK ENDOSCOPY; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number UNKNOWN

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Continued from age at time of event: the average age was 62 years old (range 58 to 66 years).Continued from gender: three patients were included (two females, one male).Continued from date of event: the abstract was published in 2019 and the exact date is unknown.Salcedo, j., pearlman, m., & barkin, j.(2019).Failure of withdrawal through the abdominal wall - a new percutaneous gastrostomy tube placement complication: a case series.The american journal of gastroenterology, 0, s1052.The investigation is ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

Cook endoscopy was notified of this event involving a flow 20 pull® peg tube involving one patient published in 2019.Please see below for relevant excerpts of this abstract.¿.Three patients were included (two females, one male).The average age was 62 years old (range 58 to 66 years).All of the cases presented unsuccessful peg placement using the flow 20 pull® peg tube (cook medical®, winston-salem, north carolina).Two of the three patients had pneumoperitoneum, one with generalized peritonitis (subject of report) after the failed peg attempt, requiring exploratory laparotomy.This is the first report of patients with unsuccessful peg placement secondary to the inability to withdraw the gastrostomy tube through the abdominal wall.Failure was likely caused from the tangential entrapment of the peg tube tip in the gastric wall or subcutaneous tissue.We hypothesize that this may be related to the short and blunt - shaped tip of the flow 20 pull® peg tube (cook medical®)." it was not published in the abstract if a section of the device remained inside the patient's body.One of the patients developed generalized peritonitis.An exploratory laparotomy was potentially completed as a result, however, it is unclear based on the article if the exploratory laparotomy was done as a result of the pneumoperitoneum or the peritonitis.A separate report is being completed to capture the pneumoperitoneum potentially requiring exploratory laparotomy.

Manufacturer Narrative

Continued from date of event: the abstract was published in 2019 and the exact date is unknown.Salcedo, j., pearlman, m., & barkin, j.(2019).Failure of withdrawal through the abdominal wall - a new percutaneous gastrostomy tube placement complication: a case series.The american journal of gastroenterology, 0, s1052.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 summary: 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 instructions for use (ifu) states, "potential complications associated with placement and use of a percutaneous endoscopic gastrostomy (peg) tube include, but are not limited to: bronchopulmonary aspiration and pneumonia, respiratory distress or airway obstruction, peritonitis or septic shock, colocutaneous, gastrocolocutaneous or small bowel fistula, gastric dilation, sigmoid intra-abdominal herniation and volvulus, persistent fistula following peg removal, gastric dilation, esophageal injury, necrotizing fasciitis, candida cellulitis, improper placement or inability to place peg tube, tube dislodgement or migration, hemorrhage, and tumor metastasis.Additional complications include, but are not limited to: pneumoperitonuem, peristomal wound infection and purulent drainage, stomal leakage, bowel obstruction, gastroesophageal reflux (gerd), and blockage of deterioration of the peg tube.".Prior to distribution, all percutaneuous endoscopic gastrostomy sets are subjected to a visual inspection and functional testing 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 Description

Cook endoscopy was notified of this event involving a flow 20 pull® peg tube involving one patient published in 2019.Please see below for relevant excerpts of this abstract.¿.Three patients were included (two females, one male).The average age was 62 years old (range 58 to 66 years).All of the cases presented unsuccessful peg placement using the flow 20 pull® peg tube (cook medical®, winston-salem, north carolina).Two of the three patients had pneumoperitoneum, one with generalized peritonitis (subject of report) after the failed peg attempt, requiring exploratory laparotomy.This is the first report of patients with unsuccessful peg placement secondary to the inability to withdraw the gastrostomy tube through the abdominal wall.Failure was likely caused from the tangential entrapment of the peg tube tip in the gastric wall or subcutaneous tissue.We hypothesize that this may be related to the short and blunt - shaped tip of the flow 20 pull® peg tube (cook medical®).".Additional information was received on 6 july 2020 from the user facility that states ".We see no clear indication of reported failure of any medical device." "after careful review, we were not able to determine patient harm or risk exposure to the findings.Each of the patients was clinically compromised, and the events that occurred were known complications.In addition, there were over 160+ of the same items utilized/implanted with on other patients without similar outcomes.".It was not published in the abstract if a section of the device remained inside the patient's body.One of the patients developed generalized peritonitis.An exploratory laparotomy was potentially completed as a result, however, it is unclear based on the article if the exploratory laparotomy was done as a result of the pneumoperitoneum or the peritonitis.A separate follow-up report is being completed to capture the pneumoperitoneum potentially requiring exploratory laparotomy.

• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10168228
• MDR Text Key: 201000387
• Report Number: 1037905-2020-00246
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K920703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MANUFACTURER OR MODEL.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR