MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION PVC THORACIC CATHETERS; CATHETER, CHOLANGIOGRAPHY

Model Number	8124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of our investigation.
Event or Problem Description
Report received stated that two abdominal drains were inserted intraoperatively.The drains were subsequently removed on the ward.Following removal, the patient experienced abdominal pain, leading to a ct investigation.Imaging revealed a piece of one of the catheter's was in the patient.
Additional Manufacturer Narrative
Additional information section: h6.A complaint was reported directly to tga where it was stated that "two abdominal drains were inserted intraoperatively.The drains were subsequently removed on the ward.Following removal, the patient experienced abdominal pain, leading to a ct scan which revealed imaging of a piece of one of the drain catheters." although the description says that a piece of a drain was seen in the ct scan, the report provides the part number for a pvc catheter (p/n 8124, lot number unknown).They are claiming that when the catheter was removed, a piece of it broke off inside the patient.It is not clear how large a piece broke off.This catheter has a 90 degree angle in it on the proximal end, where the eyelets are located.It is possible that if the person removing the catheter did not know about the angle or did not use proper technique removing it, that the catheter could have been damaged in the process.The amount of force needed to break the catheter would most likely be felt by the user and patient.Per the product requirements in dd003510 rev 12, the tensile strength of thoracic catheters must be at least 6.35 lbf.If the catheter is placed correctly in the thorax, it would be unlikely to exceed that amount of force when pulling it out.When removing the catheter, it should be able to slide out of the patient with minimal resistance.The report states that the patient experienced the pain "following removal" and not during.This suggests that the catheter was not caught on something internally as it was being removed.If that is the case, in order for a piece to break off, it likely would have needed to already be damaged before placement.The catheter used is a 24 fr pvc taper-tip catheter.The ifu instructs the user to cut this type of catheter at the "bubble" on the distal end following insertion.The distal end is where the catheter connects to the patient tube of a drain, but if a user were to mistakenly make a cut on the wrong end, that could allow the proximal tip of the catheter to break off while being removed.Unfortunately, as this report was received from tga and not from the user, additional information could not be provided.The device was not returned for evaluation.Pictures were not provided.And the lot number was not provided.No information about the patient was provided.A dhr review could not be completed because no lot number was provided.No evidence has been identified to indicate that manufacturing or design contributed to this complaint.The ifu provides adequate instructions for the setup and use of the device.A recurring lot number report could not be completed because no lot number was provided.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review was completed which found no similar complaints.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.There was not enough information provided with this complaint to determine a root cause and no additional information could be obtained, therefore the complaint is not able to be confirmed, nor a device nonconformance is confirmed.The root cause is impossible to define.
Event or Problem Description
N/a.

• Brand Name: PVC THORACIC CATHETERS
• Common Device Name: CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 22294519
• Report Number: 3011175548-2025-000006
• Device Sequence Number: 20926312
• Product Code: GBZ
• UDI-Device Identifier: 20650862132247
• UDI-Public: (01)20650862132247
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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 Model Number: 8124
• Device Catalogue Number: 8124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown