MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN SILICONE HYDRO-COATED DOUBLE LOOP URETERAL STENT; STENT, URETERAL

Model Number AJ42E41002

Device Problems Disconnection (1171); Fracture (1260); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, after usual connection of the pusher on the jj stent, then the placement of the jj stent in the kidney, it was impossible to release the jj stent.The traction of the blue luer caused a rupture of the white tube of the pusher while the jj stent was still connected.The patient had to return to surgery under endoscopy to remove the jj stent with the pusher part and a new jj stent was placed.

Manufacturer Narrative

Evaluation of the returned product found the pusher and its internal tube were broken near the connector, and the jj stent is broken on the vesical loop side.It was suspected this was due to excessive force.Testing was also performed on a device of the same lot received from the distribution site; connection and disconnection conformed.The issue regarding pusher length is known and a corrective and preventive action (capa) is underway.Corrections: h6 code a1203 ¿disconnection¿ corrected to a0506 ¿mechanical jam¿ and a40101 ¿fracture¿.

• Brand Name: IMAJIN SILICONE HYDRO-COATED DOUBLE LOOP URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda MN 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13361194
• MDR Text Key: 284509307
• Report Number: 9610711-2022-00005
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: AJ42E41002
• Device Catalogue Number: AJ42E4
• Device Lot Number: 8373130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention