MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA64181002
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Investigation of similar complaints received regarding a similar issue found customers had used the transversal pre-cuts on the inner pouch, and inadvertently pinched the distal end of the catheters while opening the package.Consequently, the distal end of the catheters broke before use.A longitudinal pre-cut has since been added on the inner peel pouch to aid in the opening of the package and to avoid such an effect.It was concluded that while tearing the transversal pre-cut on the packaging, the customer likely also tore the distal tip of the catheter without noticing.
Event or Problem Description
According to the available information, after insertion of the catheter, the distal tip was no longer in place.It "probably detached" and was not found in the patient after cystoscopy.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12240825
• Report Number: 9610711-2021-00060
• Device Sequence Number: 19945320
• Product Code: EZL
• UDI-Device Identifier: 03600040130087
• UDI-Public: 03600040130087
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: AA64181002
• Device Catalogue Number: AA6418
• Device Lot Number: 5719545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 07/28/2021
• 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