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

Model Number	8012
Medical Device Problem Codes	Fitting Problem (2183); Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When using 8012 with 19918 connector - staff had to 'stuff' catheter connector into catheter and really work to get them to fit.Said originally they thought the catheter connector (19918) was too small for 8012.8012 catheter 'bubble' is barely perceptible or not able to be felt at all, per staff.After some struggle, were able to get catheter onto first rib of connector.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
Additional information states: the customer ended up using 3612-100 for the procedure on (b)(6) 2024, and a borrowed 12fr catheter.We're doing a 'dry run' beforehand, when we met over teams on (b)(6) 2024, they were planning to use a 3600-100 drain and (b)(6) connector.
Additional Manufacturer Narrative
Additional information: sections b5, d4- lot # & expiration date, & h4.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Related mfg report number for additional device: 3011175548-2024-0000237.This complaint reports that hospital staff was preparing to set up a 3600-100 drain on a patient with a 12 fr catheter (p/n 8012, l/n 239793 & 235346) using a p/n 19918 connector.The customer also mentioned that the catheter's "bubble" was barely perceptible.The "bubble" is a slightly expanded portion of the catheter adjacent to the tapered end.The ifu instructs the user to cut the catheter at the bubble before attempting to connect it to a connector.The expanded portion on 12 fr catheters is very small and may not be very noticeable.It is not clear if the customer cut the catheter at the bubble.If they did not, then attempting to fit the tapered end of the catheter over the connector could explain the difficulty they experienced.They had difficulty fitting the catheter over the connector, but were able with some effort to get it "onto the first rib" of the connector.During communication with the customer, they stated that two catheters were used (the second is documented in complaint (b)(4)) while testing the setup.For the actual procedure, they used a 3612-100 drain instead and did not report any issues with that.The customer provided pictures of the 8012 catheter connected to the 19918 connector.The pictures are a little blurry, so it is difficult to tell exactly how far up the connector they got the catheter.They reported that they got it over the first barb, but the picture may show it just up to but not quite over the first barb.No devices were returned for evaluation.Prior to a procedure, the customer was testing the fit of a 3600-100 drain to a 8012 catheter.3600-100 drains do not include a connector that fits with a 12 fr catheter, so the customer used a 19918 connector, which can connect to a 3600-100 drain on one end and to a 12 fr catheter on the other.The customer reported difficulty sliding the catheter onto the connector, but were able to do it, as shown in the pictures they provided.While attaching small sized catheters to their connectors can be difficult, this ensures a tight fit to prevent the connection breaking or allowing air leaks.Nothing about the complaint description or pictures seems to be abnormal, other than the choice of drain to use with the 12 fr catheter.None of the devices discussed in the complaint were used in a procedure.For the actual procedure, a pediatric drain (3612-100) was used, which has an included connector that can connect to a 12 fr catheter.No issues were reported with the use of the 3612-100 or from the procedure itself.To test the difficulty of the connection, a 8012 catheter and 19918 connector were connected, which required some effort, but was ultimately successful.A dhr review was completed and no anomalies were identified.A recurring lot number report was completed which found no additional complaints involving lot me239793.A review of crs/capas found none related to this complaint.The ifu provides adequate instructions for the setup and use of the device.The user seemed aware of the instructions for the device.Review of the part specifications for the catheter and connector revealed that a likely cause of the event is if the catheter was not cut at the bubble, which is possible because the user reported that they had difficulty seeing it.This complaint is confirmed but a device nonconformance is not.The root-cause of this complaint is impossible to define.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.

• 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: 20507611
• Report Number: 3011175548-2024-000023
• Device Sequence Number: 7920122
• Product Code: GBZ
• UDI-Device Identifier: 20650862130120
• UDI-Public: (01)20650862130120(17)05072027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2024

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: 8012
• Device Catalogue Number: 8012
• Device Lot Number: ME239793
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/04/2024; 12/12/2024; 12/13/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/12/2024; 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: 19918 CONNECTOR
• Patient Sex: Unknown