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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COAPTECH PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID

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COAPTECH PUMA-G SYSTEM FEEDING TUBE PLACEMENT AID Back to Search Results
Model Number 0010112
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Gastrointestinal Hemorrhage (4476); Melena (4480)
Event Date 08/03/2020
Event Type  Death  
Event Description
Puma-g system used to complete a percutaneous ultrasound gastrostomy (pug) procedure on (b)(6) 2020 with no issues or bloody output found. The patient was noted as hemodynamically stable without bleeding on (b)(6) 2020 but reporting 2x supra-therapeutic partial thromboplastic times (ptt) of 205 (goal is 70-90). On (b)(6) 2020, the ptt remained elevated 112-155 ranges, then the patient experienced a hemoglobin drop, followed by melena and later bright red blood per rectum (brbpr). While prepping for a-line placement, the patient's heart rate dropped, the patient became asystolic and the patient died approximately 48 hours post-procedure with no resuscitation or extraordinary measures taken due to do not resuscitate status.
 
Manufacturer Narrative
Note that this case and the associated adverse events were reviewed as part of a retrospective study in progress at the (b)(6) medical center ((b)(6)) and (b)(6) medical center ((b)(6)). Therefore, the date of occurrence is much earlier than the date of awareness. Immediately post-procedure, there were no apparent clinical concerns from the use of the puma-g system and no evidence of a bleed. There was no apparent device misuse or malfunction.
 
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Brand NamePUMA-G SYSTEM
Type of DeviceFEEDING TUBE PLACEMENT AID
Manufacturer (Section D)
COAPTECH
101 w dickman st
suite 900
baltimore MD 21230
Manufacturer (Section G)
COAPTECH
101 w dickman st
suite 900
baltimore MD 21230
Manufacturer Contact
101 w dickman st
suite 900
baltimore, MD 21230
4435746981
MDR Report Key14214863
MDR Text Key290137887
Report Number3015177732-2022-00002
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2021
Device Model Number0010112
Device Lot Number726752
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
GASTROSTOMY TUBE.; HEPARIN INFUSIONS.
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