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

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.

• Brand Name: DORMIA NSTONE 4 HEL WIRE CH04
• Type of Device: URETERAL 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 Key: 9713831
• MDR Text Key: 179510361
• Report Number: 9610711-2020-00006
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2017
• Device Model Number: EXT2241002
• Device Catalogue Number: EXT224
• Device Lot Number: 4700827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR