MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number PEG-24-PULL-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Laceration(s) (1946); Necrosis (1971); Internal Organ Perforation (1987); Pneumothorax (2012); Peritonitis (2252); Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2013

Event Type  Injury  

Event Description

Cook became aware of a clinical literature article involving cook peg-24-pull-s devices in korea that took place from december 2002- december 2012.The following are relevant excerpts: "peg tube placement has been proven to be a safe, effective procedure but sometimes complications can occur.Retrospective review was performed to identify the records of patients referred for peg or tube replacement at hanyang university hospital (seoul, korea) during the 10-year period between december 2002 to december 2012 (250 patients, 368 cases).A complication was considered as major if required medical intervention, tube removal, or hospitalization, including post-peg bleeding (requiring transfusion or endoscopic treatment), peristomal infection (need for peg removal), necrotizing fasciitis, peritonitis, esophageal or gastric perforation, buried bumper syndrome, tube dislodgement, intramural hematoma of esophagus, pneumoperitoneum with symptoms, and injury to an adjacent organ (liver, bowel, or spleen).[subject of this report] major complications were further divided into early (occurring within 2 days after peg) and late ones (occurring 2 days or more after peg).[major] complications were observed in 43 [patients].Major complications consisted of 21 early and 22 late complications.Early complications consisted of esophageal injuries (mucosal laceration and intramural hematoma), pneumoperitoneum, peritonitis, and necrotizing fasciitis, whereas late complications were tube dislodgement, buried bumper syndrome, peristomal infection, and necrotizing fasciitis.Major complications were associated with infection in 15 patients (peristomal infection in three, peritonitis in four, necrotizing fasciitis in three, buried bumper syndrome in four, and tube dislodgement in one); five were early and ten late complications.Most of these complications were managed without procedural or surgical intervention.Major surgery was required in one patient with peritonitis, and a minor operation (wide debridement and drainage) was needed in a patient with necrotizing fasciitis.Of 11 patients with internal bolster at upper body, major peg complications had occurred in ten patients: symptomatic pneumoperitoneum in three, tube dislodgement in two, buried bumper syndrome in two, peristomal infection requiring tube removal in one, peritonitis in one, and esophageal laceration requiring hemoclipping in one.Of three patients with internal bolster at the antrum and of six patients with internal bolster at the postero-great curvature side, major complications were found only in one, respectively.Table 1 outlines the following data: major complications- 43, which include: mucosal laceration of esophagus with hemoclipping- 6, intramural hematoma of esophagus- 1, symptomatic pneumoperitoneum 9, peritonitis- 4, necrotizing fasciitis- 1, buried bumper syndrome- 7, peristomal infection requiring tube removal-3, necrotizing fasciitis-2.Note: these events are under investigation.Separate reports may be sent upon completion of the investigation to separately capture different severites of the complications.

Manufacturer Narrative

This article is under investigation.A follow up emdr will be provided.Doi: 10.1007/s10620-013-2891-7.

Manufacturer Narrative

This article remains under investigation.A follow up emdr will be provided.Doi: (b)(4).

Manufacturer Narrative

Doi: 10.1007/s10620-013-2891-7.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.Esophageal injury and pneumoperitoneum are known clinical complications.There is no evidence to suggest the report is due to a device failure.The ifu states the following potential complications: ¿potential complications associated with placement and use of a 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 bowl fistula, gastric dilation, sigmoid intra-abdominal herniation and volvulus, persistent fistula following peg removal, esophageal injury, necrotizing fasciitis, candida cellulitis, improper placement of inability to place peg tube, tube dislodgement or migration, hemorrhage, and tumor metastasis." the ifu also states, "additional complications include, but are not limited to: pneumoperitoneum, peristomal wound infection and purulent drainage, stomal leakage, bowel obstruction, gastroesophageal reflux (gerd), and blockage or deterioration of the peg tube." prior to distribution, all peg 24 percutaneous endoscopic gastrostomy set - pull are subjected to a visual and functional inspection to ensure device integrity.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

The following was originally reported: "cook became aware of a clinical literature article involving cook peg-24-pull-s devices in korea that took place from december 2002- december 2012.The following are relevant excerpts: "peg tube placement has been proven to be a safe, effective procedure but sometimes complications can occur.Retrospective review was performed to identify the records of patients referred for peg or tube replacement at hanyang university hospital (seoul, korea) during the 10-year period between december 2002 to december 2012 (250 patients, 368 cases).A complication was considered as major if required medical intervention, tube removal, or hospitalization, including post-peg bleeding (requiring transfusion or endoscopic treatment), peristomal infection (need for peg removal), necrotizing fasciitis, peritonitis, esophageal or gastric perforation, buried bumper syndrome, tube dislodgement, intramural hematoma of esophagus, pneumoperitoneum with symptoms, and injury to an adjacent organ (liver, bowel, or spleen).[subject of this report] major complications were further divided into early (occurring within 2 days after peg) and late ones (occurring 2 days or more after peg).[major] complications were observed in 43 [patients].Major complications consisted of 21 early and 22 late complications.Early complications consisted of esophageal injuries (mucosal laceration and intramural hematoma), pneumoperitoneum, peritonitis, and necrotizing fasciitis, whereas late complications were tube dislodgement, buried bumper syndrome, peristomal infection, and necrotizing fasciitis.Major complications were associated with infection in 15 patients (peristomal infection in three, peritonitis in four, necrotizing fasciitis in three, buried bumper syndrome in four, and tube dislodgement in one); five were early and ten late complications.Most of these complications were managed without procedural or surgical intervention.Major surgery was required in one patient with peritonitis, and a minor operation (wide debridement and drainage) was needed in a patient with necrotizing fasciitis.Of 11 patients with internal bolster at upper body, major peg complications had occurred in ten patients: symptomatic pneumoperitoneum in three, tube dislodgement in two, buried bumper syndrome in two, peristomal infection requiring tube removal in one, peritonitis in one, and esophageal laceration requiring hemoclipping in one.Of three patients with internal bolster at the antrum and of six patients with internal bolster at the postero-great curvature side, major complications were found only in one, respectively.Table 1 outlines the following data: major complications- 43, which include: mucosal laceration of esophagus with hemoclipping- 6.Intramural hematoma of esophagus- 1.Symptomatic pneumoperitoneum 9.Peritonitis- 4.Necrotizing fasciitis- 1.Buried bumper syndrome- 7.Peristomal infection requiring tube removal-3.Necrotizing fasciitis-2.Note: these events are under investigation.Separate reports may be sent upon completion of the investigation to separately capture different severites of the complications." the subject of this report is now the six patients who experienced mucosal laceration of esophagus with hemoclipping, and the nine patients who experienced symptomatic pneumoperitoneum.Various intervention methods were performed.The other adverse events will be reported in separate emdrs.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Type of Device: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 14458858
• MDR Text Key: 293284863
• Report Number: 1037905-2022-00232
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PEG-24-PULL-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention