MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AXIUS CORONARY SHUNT 1.0 MM; CLAMP, VASCULAR

Model Number	AXIUS CORONARY SHUNT 1.0 MM
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id #(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
Related to (b)(4).The hospital reported that they received axius coronary shunt 1.0 mm.On 19.04 the customer receives 2 conf.Ni cod.C-of-1000 with expiry 07-2021.- (b)(6).Cannot accept this deadline.Procede with the customer return and relative return to the supplier.Forward a new po and xpo resends the same product again with the same expiry despite my mail - (b)(6).Asked the customer to refuse the package.No patient involvement.
Additional Manufacturer Narrative
Trackwise # 490061 updated sections: g4, g7, h2, h3, h6, h10 analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis for similar complaints: (4109/213/67) there were 10 additional similar complaint(s) reported for the reported failure mode and the reported lot number.However, no specific failure was reported.Trend analysis: (4110/213/67) the overall ¿axius shunt¿ 24 month complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.The overall complaint rate was found to be 0.269% and is above +3sd.Statement: run rule triggered above +3sd in (b)(6) 2021 for the overall control chart and failure mode- "shelf life exceeded" addressed under crf.No negative trend in biocompatibility related complaints have been observed.(i.E skin irritation, fever, skin infection, inflammation, allergic reaction, endotoxcity, hypersensitivity).Refer to escalation slide for details.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/213/67) the device was returned to the factory for evaluation on (b)(6) 2021.An investigation was conducted on (b)(6) 2021.There were no signs of clinical use or evidence of blood as the product was returned unopened in its original packaging.The expiration date on the package was observed to be 2021-07-27.An email was sent to request the po information when the device was delivered to the account.Two deliveries of the product to the account were shipped on (b)(6) 2021, as well as (b)(6) 2021, well before the expiration date of the products.Based on the returned condition of the device, as well as the po information received, the reported failure "no apparent adverse event¿ was not confirmed as no specific failure was reported.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).
Event or Problem Description
N/a.

• Brand Name: AXIUS CORONARY SHUNT 1.0 MM
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12161128
• Report Number: 2242352-2021-00575
• Device Sequence Number: 4723490
• Product Code: DXC
• UDI-Device Identifier: 00607567700598
• UDI-Public: 00607567700598
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K010117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2021

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 Expiration Date: 07/27/2021
• Device Model Number: AXIUS CORONARY SHUNT 1.0 MM
• Device Catalogue Number: C-OF-1000
• Device Lot Number: 25152835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 11/12/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/10/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose