MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER MINI-LOOP DRAINAGE SET LOCKING 8F X 25CM

Model Number	758608025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During catheter exchange, after positioning the new catheter, the lock on the pigtail fixation wire broke.Making it impossible to use.It is not the first occurrence of a catheter quality deviation, and previous ones were not formally notified.Attached is the image of the identified problem.As a result, it led to an increase in the procedure time in the patient undergoing radio intervention, rework of professionals, and waste of material.Customer internal notification no.: (b)(4).
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
During catheter exchange, after positioning the new catheter, the lock on the pigtail fixation wire broke.Making it impossible to use.It is not the first occurrence of a catheter quality deviation, and previous ones were not formally notified.Attached is the image of the identified problem.As a result, it led to an increase in the procedure time in the patient undergoing radio intervention, rework of professionals, and waste of material.Customer internal notification no.: 2023.07.074.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of photos from the customer was performed, found locking tab was broke and the complaint was confirmed.The most probable root causes are final packaging configuration, shipping, unit storage, mishandling by operator, after reaching the customer facility or damage prior to use.No corrective action will be taken at this time.However, this issue has been documented and argon will continue to monitor for this issue in the future.

• Brand Name: SKATER MINI-LOOP DRAINAGE SET LOCKING 8F X 25CM
• Common Device Name: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17586493
• Report Number: 0001625425-2023-01163
• Device Sequence Number: 5045417
• Product Code: GBO
• UDI-Device Identifier: 00886333225408
• UDI-Public: 00886333225408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 758608025
• Device Lot Number: 11434495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown