MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,study report with the FDA on 2018-12-04 for N/A manufactured by Cook Inc.
[129298652]
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 pma/510(k) #: 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.
Patient Sequence No: 1, Text Type: N, H10
[129298653]
The below description of catheter maintenance issues was found 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 (1820334-2018-03493) records one (b)(6) female who experienced tube occlusion 10 days after insertion. Occlusion was demonstrated with contrast and the filling of the stomach through proximal side holes. A 0. 035in guide wire was placed through the catheter and the device was exchanged for a new one of the same type. 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 (b)(6) 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. One repositioning procedure occurred due to leakage in a (b)(6) female and is recorded under medwatch report #1820334-2018-03492. One (b)(6) 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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03493 |
| MDR Report Key | 8129719 |
| Report Source | LITERATURE,STUDY |
| Date Received | 2018-12-04 |
| Date of Report | 2019-01-30 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2018-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GCE |
| Date Received | 2018-12-04 |
| Model Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-04 |