MAUDE Adverse Event Report: AXIOM MEDICAL INC AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETER; WOUND DRAIN

Model Number	111120AT
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated crystallized material formed inside the tube causing narrowing of the inner lumen.Customer flushed the catheter with plasma-lyte solution, ph 7.4.Following the flush, the patient experienced tamponade.The customer is concerned the crystals in the tube were the cause of the tamponade.
Additional Manufacturer Narrative
This complaint is within the scope of capa (b)(4).Device was discarded by healthcare facility and was not returned to the manufacturer.Complaint log f-1b has been reviewed for other relevant or similar events.Reference complaint numbers and make notes as necessary to describe relevance: sales history for item 111120at, lot 1802384r, bowers, 1 box, 11-13-18 , cardiomedics, 6 boxes, 7-13-18 and 9-17-18, long beach memorial, 1 box, 10-17-18, tri-anim, 9 boxes, 6-29-18, 7-19-18, and 2-7-19.No complaint other than from nicklaus children's hospital (tri-anim) samples tested from same lot performed to specification after being soaked per instructions on label.The review of in-process controls and review of device feedback support the conclusion that this is an isolated issue.The 'crystals' referenced in the complaint description refers to the coating before it is lubricated, suggesting that the user did not soak the catheters prior to use.Based on available information, the likely root cause is related to user error - not soaking the catheters per instructions.Due to esg issues, reporting was delayed to (b)(6) 2021.On (b)(6) 2021, a ticket 275008 was opened requesting web trader account setup.Verification email was never received after initial registration.There have been technical difficulties getting a secondary test account and communication with the esg help desk is ongoing as of due date (b)(6) 2021.
Additional Manufacturer Narrative
This complaint is within the scope of capa (b)(4).Device was discarded by healthcare facility and was not returned to the manufacturer.Complaint log f-1b has been reviewed for other relevant or similar events.Reference complaint numbers and make notes as necessary to describe relevance: sales history for item 111120at, lot 1802384r, bowers, 1 box, 11-13-18 , cardiomedics, 6 boxes, 7-13-18 and 9-17-18, long beach memorial, 1 box, 10-17-18, tri-anim, 9 boxes, 6-29-18, 7-19-18, and 2-7-19.No complaint other than from nicklaus children's hospital (tri-anim) samples tested from same lot performed to specification after being soaked per instructions on label.The review of in-process controls and review of device feedback support the conclusion that this is an isolated issue.The 'crystals' referenced in the complaint description refers to the coating before it is lubricated, suggesting that the user did not soak the catheters prior to use.Based on available information, the likely root cause is related to user error - not soaking the catheters per instructions.Due to esg issues, reporting was delayed to (b)(6) 2021.On (b)(6) 2021, a ticket (b)(4) was opened requesting web trader account setup.Verification email was never received after initial registration.There have been technical difficulties getting a secondary test account and communication with the esg help desk is ongoing as of due date (b)(6) 2021.
Event or Problem Description
Customer stated crystallized material formed inside the tube causing narrowing of the inner lumen.Customer flushed the catheter with plasma-lyte solution, ph 7.4.Following the flush, the patient experienced tamponade.The customer is concerned the crystals in the tube were the cause of the tamponade.

• Brand Name: AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETER
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): AXIOM MEDICAL INC; 19320 south van ness ave.; torrance CA 90501
• Manufacturer Contact: valerie ramsay ; 19320 south van ness ave.; torrance, CA 90501 ; 3105339020
• MDR Report Key: 12853799
• Report Number: 2020735-2021-00001
• Device Sequence Number: 11914381
• Product Code: GBS
• UDI-Device Identifier: M665111120AT0
• UDI-Public: M665111120AT0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K883887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 111120AT
• Device Catalogue Number: 111120AT
• Device Lot Number: 1802384R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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
• Patient Sex: Unknown