MAUDE Adverse Event Report: COLOPLAST A/S MANUFACTURING X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AB6B201002

Device Problems Difficult or Delayed Positioning (1157); Material Perforation (2205)

Patient Problems Pain (1994); Perforation (2001); Unspecified Tissue Injury (4559)

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 the available information, multiple episodes of urethral trauma and catheter tip misplacement at the end of turp procedures.Some catheters have ended up outside the bladder posteriorly.Others have caused significant urethral trauma on insertion with possible long-term sequelae for patients.It was reported that likely cause was the stiffness of the catheters, and the ¿raised¿ balloon area of the catheters.It was not reported how many patients experienced these complications.

• Brand Name: X-FLOW CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usjki jennifer kinneman ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11611823
• MDR Text Key: 260517192
• Report Number: 9610711-2021-00029
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB6B201002
• Device Catalogue Number: AB6B20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other