MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; FOLEY CATHETER

Model Number	AA61121002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot number 7138606.20 similar cases were found for aa6112 for bursts balloon since the ce marking.The product reference aa61121002 lot number 7138606 as made with the intermediate product aa611280 lot number 6851770.No sample is available from the customer and we cannot go further than the documentary investigation which didn't reveal any anomaly recorded during production.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.In parallel, a specific trend is monitored regarding the silicone balloon issue.
Event or Problem Description
According to the available information, the balloon burst upon inflation when attempting to insert catheter.It was reported that hospital policy and catheter instructions were followed.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10140343
• Report Number: 9610711-2020-00019
• Device Sequence Number: 16685434
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 03600040127230
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 06/09/2020

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 Expiration Date: 10/28/2024
• Device Model Number: AA61121002
• Device Catalogue Number: AA6112
• Device Lot Number: 7138606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1