MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT ACT KAOLIN CARTRIDGE

Catalog Number	03P87-25
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2021, abbott point of care was contacted by a customer regarding act kaolin cartridges that yielded multiple code 26 on a (b)(6) male patient with acute st elevation myocardial infarction (stemi) due to occlusion of circumflex coronary artery.This patient's procedure was not completed and the patient was transferred to another facility.Customer states there was heavy calcification was noted in the rca lesion with residual 98% lesion.Unable to cross the calcified lesion with a bigger diameter balloon.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).At this time there is no reason to suspect a malfunction exists.An investigation is underway.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 18-jan-2022.A review of the device history record (dhr) confirmed the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ag (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.

• Brand Name: I-STAT ACT KAOLIN CARTRIDGE
• Common Device Name: ACT KAOLIN CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 13170143
• Report Number: 2245578-2022-00001
• Device Sequence Number: 11203718
• Product Code: JBP
• UDI-Device Identifier: 10054749000156
• UDI-Public: 10054749000156
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K023582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 03/29/2022
• Device Catalogue Number: 03P87-25
• Device Lot Number: R21273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Male