MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH18; SILICONE CATHETER

Model Number	AA64181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found one similar complaint on this lot.The product final aa64181002 folysil overguide 5/15ml ch18 lot 6328227 for 945ea has been manufactured in june 2018 and the expiry date is june 2023.Checking the quality databases revealed no anomaly in connection with the described defect.The sample returned was put in a simulation bath from february 12th until february 26th - the result of the test shows a balloon conform.The balloon burst issue is known and monitored on a monthly basis.Possible root cause is a weakness area in the silicone material of the balloon.No other corrective action will be implemented as the specific trend for balloon deflating and this product family has an average which is considered acceptable as per the threshold.
Event or Problem Description
According to the available information, when refilling the balloon, the balloon burst, the red valve is leaking.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH18
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8382026
• Report Number: 9610711-2019-00011
• Device Sequence Number: 1104651
• Product Code: EZL
• UDI-Device Identifier: 03600040130087
• UDI-Public: 03600040130087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013174
• 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
• Report Date (Section B): 02/25/2019

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: AA64181002
• Device Catalogue Number: AA6418
• Device Lot Number: 6328227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• 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