MAUDE Adverse Event Report: COOK INC

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Suspect medical device: product described as a 14f dawson-mueller g/gj catheter with a locking loop.Specific device information was unable to be determined.Concomitant products: unspecified gastropexy sutures, unspecified nasogastric tube or 5f cook kumphe catheter.Specific product information unknown.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The below description of catheter maintenance issues was described in the following article: owen o'connor, elizabeth diver, shaunagh mcdermott, et al."palliative gastrostomy in the setting of voluminous ascites." j palliat med 17.7 (2014): 811-821.The article describes a retrospective review of imaging, procedure details, outcomes, and complications of percutaneous gastrostomy/gastrojejunostomy (g/gj) in patients with voluminous ascites.The g/gj catheter typically used was a 14f dawson-mueller catheter with a locking loop.Sixty-six primary g and three primary gj insertions were performed during the study (69 patients: 14 male, 55 female, mean age 58 ¿ 12 years, range 32¿89 years).Almost 90% of patients had ascites due to a malignant disease.Most insertions in patients with malignant disease were to relieve small bowel obstruction.Insertions in patients with benign disease were for feeding (most commonly due to cirrhosis with neurological impairment).Devices were placed under fluoroscopic or ct guidance.Due to patient conditions, ten patients died in the hospital after insertion (per the author, "these other patients died outside the periprocedural reference period of one month.These patients died as a result of their cancer.They were included in the survival analysis (which unfortunately was very short for most of these patients due to the nature of their disease)¿).The average survival time available for the remaining patients was 43 days after insertion.There were 28 major complications reported after g/gj insertion.This medwatch report (1820334-2018-03492) records a (b)(6) year old female who required a repositioning procedure due to leakage.This woman had gastric obstruction and ascites due to pancreatic carcinoma.Initial imaging showed the tip of the g tube projected over the distal esophagus region.The tube was manipulated under fluoroscopic guidance and the tip repositioned to the distal stomach.The other complications include thirteen tubes that fell out, twelve of which occurred in unspecified patients and are recorded under medwatch report #1820334-2018-03552.The thirteenth tube dislodgement occurred in one 75 year old patient with ovarian carcinoma, ascites, and small bowel obstruction.This patient complication is recorded under medwatch report #1820334-2018-03553.Six patients experienced leakage, five of which were unspecified and are recorded under medwatch report #1820334-2018-03554.One leakage patient was stated to also experience skin excoriation due to leakage.This patient required direct treatment to treat the excoriation and is recorded under medwatch report #1820334-2018-03486.Four tubes required repositioning within the stomach resulting in a repositioning procedure, three of which are unspecified and are recorded under medwatch report #1820334-2018-03491.The 4th repositioning procedure is recorded under this medwatch report.One (b)(6) year old female experienced tube occlusion 10 days after insertion and is recorded under medwatch report #1820334-2018-03493.One (b)(6) year old female experienced hematemesis following g tube insertion.This patient is recorded under medwatch report #1820334-2018-03494.It was also reported that one patient expired due to failed gastropexy.The failed gastropexy resulted in peritoneal leakage and sepsis.This event was noted to be unrelated to the type of catheter by the physician upon further questioning.It is stated these issues resulted in additional procedures such as catheter replacement, repositioning, and/or increased the level of care that the patients required.Per correspondence with the author, these issued were generally treated without adverse effect.Additionally, per the author, " i don¿t have data on the individual patients.I don¿t have data on the exact catheter in question".
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a review of the drawing, instructions for use, manufacturing instructions, and quality control of the device was conducted during the investigation.Additionally, images of the device which were included in the source material were reviewed as part of the investigation.The evaluation of the provided images confirmed that the catheter migrated out of the correct positioning and into the distal esophagus.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.- attachment: [o_connor_-_palliative_gastrostomy_in_the_setting_of_voluminous_ascites.Pdf].

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8129527
• Report Number: 1820334-2018-03492
• Device Sequence Number: 15418638
• Product Code: GCE
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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: Required Intervention
• Patient Age: 44 YR