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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S DORMIA NSTONE 4 HEL WIRE CH04 URETERAL STONE DISLODGER

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COLOPLAST A/S DORMIA NSTONE 4 HEL WIRE CH04 URETERAL STONE DISLODGER Back to Search Results
Model Number EXT2241002
Device Problem Mechanical Problem (1384)
Patient Problems Death (1802); Fistula (1862); Septic Shock (2068); No Information (3190)
Event Date 06/29/2016
Event Type  Death  
Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 4700827. Checking the quality databases revealed no anomaly in connection with the described defect. Unfortunately no sample is available from the customer and we cannot go further than the documentary investigation, which didn't reveal any anomaly recorded during production. The product reference ext2241002 lot 4700827 must be used for kidney stones and not for gallstones, as declared by the doctor. We believe this is a misuse of our ext224 medical device. According the instructions for use sh2138 : indications: extraction of urinary tract calculi. It is concluded that the risks identified are still acceptable and considered as safe. No similar case was found for catalog# ext224.
 
Event Description
As reported to coloplast though not verified, the patient was admitted to the hospital on (b)(6) 2016 for vesicocholédocienne lithiasis. During this intervention on (b)(6) 2016, under general anesthesia, the dormia was used in a digestive endoscope to extract gallstones. The surgeon practiced an attempt to extract the calculus by the main biliary duct, with dilation of the bile duct for the passage of a dormia. The first two passages did not bring back any stone, and during the third attempt, the dormia catheter got blocked. Pancreatitis is inevitable, and without any clinical, biological or radiographic translation, it was necessary to intervene in emergency, within twelve hours in order to extract this deleterious obstacle for the pancreatic function. On (b)(6) 2016, an intervention was performed. During this intervention, in the recovery room, the patient was victim of a massive inhalation, with an unfavorable evolution. Subsequently, she suffered a septic shock. A tracheostomy was performed on (b)(6) 2016 with complications from obstructions and skin fistulas. The trachea ct scan confirmed the two fistulas on (b)(6) 2016. The patient died on (b)(6) 2016.
 
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Brand NameDORMIA NSTONE 4 HEL WIRE CH04
Type of DeviceURETERAL STONE DISLODGER
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA 3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING FRANCE
9 avenue edmond rostand
sarlat-la-caneda, 24206
FR 24206
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, mn 
MDR Report Key9713831
MDR Text Key179510361
Report Number9610711-2020-00006
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/26/2017
Device Model NumberEXT2241002
Device Catalogue NumberEXT224
Device Lot Number4700827
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2015
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/14/2020 Patient Sequence Number: 1
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