MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH14; SILICONE FOLEY CATHETER

Model Number	AA64141002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, balloon fell off during indwelling due to balloon burst.The physician replaced with a new catheter immediately, no clinical consequences reported.No residue/particle remains in patients body.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the investigation.After receiving this complaint, we searched for other complaints and we found one similar complaint on this lot.Checking the quality databases revealed no anomaly in connection with the described defect.We did not received the expected sample.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 burst of this product family is considered acceptable as per the threshold.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH14
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8233304
• Report Number: 9610711-2019-00001
• Device Sequence Number: 10828642
• Product Code: EZL
• UDI-Device Identifier: 03600040129869
• UDI-Public: 03600040129869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/15/2019

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: AA64141002
• Device Catalogue Number: AA6414
• Device Lot Number: 6237496
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1