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 Codes	Manufacturing, Packaging or Shipping Problem (2975); 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 not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
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.- po (b)(6).Cannot accept this deadline.Rocede 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 - po (b)(6).Asked the customer to refuse the package.No patient involvement.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated sections: g4, g7, h2, h3, h6, h10, h11.Corrected section: h6 - device code change from "manufacturing, packaging or shipping problem" to "no apparent adverse event".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Corrected section: : h-6 - type of investigation corrected from ¿device not returned 4114¿ to ¿testing of actual/suspected device 10"; h6 - component code corrected from ¿mechanical| fastener|clamp 757¿ to "blank".Testing of actual/suspected device: (10 /213/67) the device was returned to the factory for evaluation on 06/21/2021.An investigation was conducted.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 12-apr-2021, as well as 20-apr-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.

• 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
• MDR Report Key: 11803593
• Report Number: 2242352-2021-00369
• Device Sequence Number: 3909125
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2021

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
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 06/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/11/2021; 07/09/2021
• Patient Sequence Number: 1