MAUDE Adverse Event Report: COLOPLAST A/S ACCESS SHEATH CH10-12 45; URETHRAL ACCESS SHEATH

Model Number AXXL101002

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

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 of 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, during the extraction of a stone of less than 2 mm with dormia, they noticed that the access sheath cracks and that pieces of plastic remove at the same time.Several plastic wires are then recovered which have been flushed towards the kidney.Consequences: obligation of withdrawal of the plastic wires.Extension of the surgical time with skeptical risk if forgetful of filaments despite careful control with the ureteroscope.

• Brand Name: ACCESS SHEATH CH10-12 45
• Type of Device: URETHRAL ACCESS SHEATH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6360853
• MDR Text Key: 68756275
• Report Number: 9610711-2017-00006
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 03600040277508
• UDI-Public: 03600040277508
• Combination Product (y/n): N
• PMA/PMN Number: K102485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AXXL101002
• Device Catalogue Number: AXXL101002
• Device Lot Number: 5246598
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other