MAUDE Adverse Event Report: COLOPLAST A/S RETRACE URETERAL ACCESS SHEATH

Model Number	ACXL101002
Medical Device Problem Codes	Complete Blockage (1094); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
According to available information, this device was not able to be used due to a defect.The device had two entry holes instead of one.It was noted the openings were closed.No other adverse patient effects were reported.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none regarding the 8298966 the sample of product acxl101002 and 8298966 was manufactured in november 2021 for (b)(4) pieces.The expiry date is november 2026.Checking the quality databases did not reveal any anomaly in relation to the described defect.On 20th march we received one used sample.Two canals in dilatator item are conformed to the specification product.However these canals are clogged at the white connector level.After observation and unclogged one of them we only observed dilatator materials.We cannot define exactly one root cause, we can supposed that is during extrusion step, however no other case was observed.We assume that is an isolated case.

• Brand Name: RETRACE URETERAL ACCESS SHEATH
• Common Device Name: URETERAL ACCESS SHEATH
• 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 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16702962
• Report Number: 9610711-2023-00052
• Device Sequence Number: 5616778
• Product Code: FED
• UDI-Device Identifier: 03600040277478
• UDI-Public: 03600040277478
• Combination Product (Y/N): N
• PMA/510(K) Number: K123675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACXL101002
• Device Catalogue Number: ACXL10
• Device Lot Number: 8298966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown