MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038102
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Thromboembolism (2654); Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Death
Event or Problem Description
The report states, "an iab was placed pre op, patient went to operating room for transplant, and patient returned from or to icu without incident.The sheath removal team removed the iab.After iab was discontinued, 'clots showered the patient and lactate levels rose'.Patient ultimately expired within 24h of iab discontinuation".Additional information received stated that the transplant the patient underwent was a heart transplant in which they received anticoagulation for in the operating room.The iab was inserted femorally, the customer did not indicate left or right.The removal of the iab was planned as iabp therapy was discontinued.The lactate level was "stable" prior to iab removal.However, at the time of this report, the customer has not returned our multiple inquiries regarding the cause of death, past medical history, patient demographics, length of iabp therapy, if the pump was paused at any time and for how long, if there was difficulty removing the iab, the full anatomic distribution of the "shower of emboli", last measured platelet count, if the patient was screened for consumptive coagulopathy, if an autopsy was performed and if results were available to us, and if the physician alleges the removal of the iab contributed to the patient's death.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
The report states, "an iab was placed pre op, patient went to or for transplant, and patient returned from or to icu without incident.The sheath removal team removed the iab.After iab was discontinued, "clots showered the patient and lactate levels rose' patient ultimately expired within 24h of iab discontinuation".Additional information received stated that the transplant the patient underwent was a heart transplant in which they received anticoagulation for in the operating room.The iab was inserted femorally, the customer did not indicate left or right.The removal of the iab was planned as iabp therapy was discontinued.The lactate level was "stable" prior to iab removal.However, at the time of this report, the customer has not returned our multiple inquiries regarding the cause of death, past medical history, patient demographics, length of iabp therapy, if the pump was paused at any time and for how long, if there was difficulty removing the iab, the full anatomic distribution of the "shower of emboli", last measured platelet count, if the patient was screened for consumptive coagulopathy, if an autopsy was performed and if results were available to us, and if the physician alleges the removal of the iab contributed to the patient's death.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4), the reported complaint for iab removal difficulty is not able to be confirmed.The product was not returned for investigation.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
The report states, "an iab was placed pre op, patient went to or for transplant, and patient returned from or to icu without incident.The sheath removal team removed the iab.After iab was discontinued, 'clots showered the patient and lactate levels rose'.Patient ultimately expired within 24h of iab discontinuation".Additional information received stated that the transplant the patient underwent was a heart transplant in which they received anticoagulation for in the operating room.The iab was inserted femorally, the customer did not indicate left or right.The removal of the iab was planned as iabp therapy was discontinued.The lactate level was "stable" prior to iab removal.However, at the time of this report, the customer has not returned our multiple inquiries regarding the cause of death, past medical history, patient demographics, length of iabp therapy, if the pump was paused at any time and for how long, if there was difficulty removing the iab, the full anatomic distribution of the "shower of emboli", last measured platelet count, if the patient was screened for consumptive coagulopathy, if an autopsy was performed and if results were available to us, and if the physician alleges the removal of the iab contributed to the patient's death.If further information is received, the compla int file will be updated.
Additional Manufacturer Narrative
(b)(4).The reported complaint for iab removal difficulty is not able to be confirmed.The product was not returned for investigation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17227701
• Report Number: 3010532612-2023-00355
• Device Sequence Number: 7207330
• Product Code: DSP
• UDI-Device Identifier: 00801902136718
• UDI-Public: 00801902136718
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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: IPN038102
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 08/03/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/31/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.; N/A.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown