MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW COUV 3WAY 50ML SI CH18; SILICONE CATHETER

Model Number	AB61181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/20/2018
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 the available information, catheter fell off after 3 days indwelling due to balloon bursts.Dr.Has replaced with new product immediately, no clinical consequences reported, also confirmed no residue or particle remains in patient's bladder.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation.After receiving this complaint, we could not search for other complaint as the lot number is not available.Unfortunately we have not been given sufficient information to perform an investigation the balloon burst issue is known and monitored.Possible root cause is a weakness area in the silicone material of the balloon.No corrective action will be implemented as the specific trend for balloon burst of this product family is considered acceptable as per the threshold.

• Brand Name: X-FLOW COUV 3WAY 50ML SI CH18
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8311082
• Report Number: 9610711-2019-00004
• Device Sequence Number: 16674300
• Product Code: EZL
• UDI-Device Identifier: 03600040143629
• UDI-Public: 03600040143629
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013172
• Number of Events Summarized: 1
• Summary Report (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): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AB61181002
• Device Catalogue Number: AB6118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other