MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Vomiting (2144); Peritonitis (2252); Abdominal Distention (2601)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.[(b)(4)_literature article.Pdf].

Event Description

It was reported in a literature article that a (b)(6) year old male patient developed peritonitis after an endoscopic caecostomy procedure where a cook chait trapdoor catheter was placed.It was decided to perform an endoscopic caecostomy using a chait trapdoor catheter to start antegrade bowel cleansing.Prior to the procedure, the patient was administered antibiotic prophylaxis (cefazolin 50 mg/kg and metronida-zole 20 mg/kg).During the procedure, after preparing the patient's colon with colopeg, a colonoscopy was performed under general anesthesia.After the caecum was reached, one set of pediatric anchors was placed under view.The tract was then dilated using an 8-f coons dilator.The physician then attempted to insert a small chait catheter stretched on its stiffener; however, "the treat of the anchors broke at skin level" and the catheter was unable to be advanced into the patient's caecum.The pediatric anchors were then replaced and the tract was dilated with a 10-f coons dilator, allowing the small chait catheter stretched on a stiffener to be advanced into the patient's caecum.During doing so, the anchors broke again as the catheter was advanced through the caecal wall.However, they were not replaced this time as "the catheter showed nice curls after removing the stiffener and the guide wire and as the caecum seemed to be pulled well against the abdominal wall".Following the procedure, antibiotics were administered intravenously for 24 hours.The catheter was rinsed with 100 ml of tap water and enteral feeding was restarted six hours after the procedure.One day post-op, the patient "developed abdominal cramps shortly after instilling the catheter with 100 ml of tap water, without any concomitant symptoms".It was reported that "abdominal examination revealed no tenderness or pain at percussion, only some crepitation of the right abdominal wall, considered as a physiologic sign after the procedure".The following day, the boy vomited clear fluid, though abdominal examination once again revealed no abnormalities apart from crepitating of the right abdominal wall, so no further examinations were performed.Hours later, the patient developed a "crepitating mass in the right hemiscrotum and complained of interscapular pain".The abdomen was distended but not painful upon palpation.A neurological examination was performed with normal results and the patient's parents reported no abnormalities.At this point, an x-ray was performed and showed extensive free intraabdominal air.A laparotomy was performed under the suspicion of potential bowel perforation or catheter dislocation.A "large amount of pus was evacuated from the abdomen", but there was no intraabdominal stool leakage.The catheter was observed through the caecal wall in the patient's colon but had "fallen down so that 1 curl of the catheter was pulled out of the caecum into the abdominal cavity".Consequently, the catheter was reinserted and the caecum was fixed to the patient's abdominal wall using absorbable sutures.Due to the large amount of intraabdominal pus, "the ventriculoperitoneal drain was exteriorized".Antibiotics were restarted, including cefazolin 50 mg/ kg/day and metronidazole 20 mg/kg/day.After three days, "klebsiella and extended-spectrum b-lactamase¿positive escherichia coli were cultured from the removed part of the ventriculo-peritoneal drain", which resulted in the administration of meropenem (antibiotic) for three days.The patient was reported to have "recovered uneventfully" and was determined to no longer need a ventriculo-peritoneal drain.The catheter was rinsed with 10 ml of tap water twice a day starting the day after the surgery.Five days after the surgery, the tap water amount used to rinse the catheter was increased to 25 ml per rinse.It was also reported that retrograde enemas were able to be stopped eight days post-op and fecal incontinence stopped complete with one antegrade enema per day.No complications due to breakdown of the anchors were reported.The patient did not develop meningitis but was reported to have "recovered well".Additional information regarding the device and event has been requested but is currently unavailable.Urology, section of pediatric.¿peritonitis after endoscopic caecostomy with a chait.: journal of pediatric gastroenterology and nutrition.¿ lww, aug.2012, journals.Lww.Com/jpgn/fulltext/2012/08000/peritonitis_after_endoscopic_caecostomy_with_a.26.Aspx.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: section d - suspect medical device: rpn: gias-100-ped, quantity 2 d2b.- product code of suspected device: fge catheter, biliary, diagnostic g5 - pma/510(k) # of suspected device: k873606 investigation ¿ evaluation it was reported that a six year old patient with spina bifida reportedly developed peritonitis after an endoscopic cecostomy with a chait trapdoor catheter.Two sets of suture anchors broke during the procedure and therefore failed to hold the caecum against the abdominal wall.This caused the caecum to retract and expose the 1st loop of the catheter.No additional suture anchors were placed.This incident was based on information from a journal article from universitair medisch centrum, in the netherlands published in 2012.It was determined during investigation of this event that no failure of the chait percutaneous cecostomy catheter occurred, but the failure of the suture anchors could have contributed to the peritonitis.Based on the information provided in the article, the likely rpn of the suture anchors is gias-100-ped.No additional information was supplied.A review of the complaint history, instructions for use (ifu), and quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) could not be performed due to lack of information provided by the complainant.For the same reason, a data base search could not be completed for additional complaints on the same lot.A sales shipment search for the user facility was conducted but a lot number could not be determined.As related non-conformances could not be confirmed and adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The product ifu,¿cope gastrointestinal suture anchor sets,¿ provides the following information to the user related to the reported failure mode: instructions for use ¿3.Attach a 10 ml syringe, half filled with contrast medium, to the introducer needle that has been preloaded with the suture anchor.4.Advance the introducer needle through the anterior abdominal wall and then rapidly thrust the needle another 2¿5 cm into the air-filled stomach.5.Remove the 10 ml syringe from the needle hub.While maintaining slight tension on the trailing suture, introduce the distal spring coil.035 inch portion of the wire guide into the needle and use it to push the suture anchor out of the needle into the stomach cavity.8.While maintaining traction on the suture anchor, secure the suture to the skin under slight tension.10.To place the second suture anchor, reintroduce the introducer needle as described in step 4.¿ based on the information provided, no inspection of returned product and the results of the investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9974610
• MDR Text Key: 196754612
• Report Number: 1820334-2020-00838
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK: 8-F COONS DILATOR, 10-F COONS DILATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR