MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN915322
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cardiac Arrest (1762); Failure of Implant (1924); Tachycardia (2095); Cardiogenic Shock (2262); Diminished Pulse Pressure (2606); Thromboembolism (2654); Unspecified Kidney or Urinary Problem (4503)
Date of Event	12/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that there were three different events on three different patients in the last six months.The report states, "in oc tober 2022 the patient had a ventricular tachycardia (vt) arrest, cardiogenic shock, and was listed for heart transplant.Admitted on 12/4/22 for advanced therapies and vad/transplant evaluation.On (b)(6) 2022, an ultra flex 7f 40 cc iabp placed in the right femoral artery for worsening cardiogenic shock.The patient was heparinized with therapeutic anti-xa and the patient was on 1:1 iabp.Later that day, the patient developed abdominal pain, which was found on cta to be secondary to arterial thrombi in the right hepatic artery and its proximal branches and in segmental branches of the left kidney, with multiple renal infarcts.On 12/31/22, the iabp was discontinued due to thrombotic/embolic complications - iabp-related arterial embolism.He also developed loss of distal pulses in the right lower extremity requiring surgery as below.Heparin induced thrombocytopenia was thought to be unlikely after clinical and laboratory assessment.The patient was anticoagulated with bivalrudin.He had worsening acute kidney injury on chronic kidney injury.Another balloon was not used.On 1/3/23, the patient underwent an embolectomy/thrombectomy of the right leg.On 1/10/23, a biventricular assist device (bivad) was placed.The patient is currently still admitted".
Event or Problem Description
It was reported that there were three different events on three different patients in the last six months.The report states, "in oc tober 2022 the patient had a ventricular tachycardia (vt) arrest, cardiogenic shock, and was listed for heart transplant.Admitted on (b)(6)22 for advanced therapies and vad/transplant evaluation.On (b)(6)22, an ultra flex 7f 40 cc iabp placed in the right femoral artery for worsening cardiogenic shock.The patient was heparinized with therapeutic anti-xa and the patient was on 1:1 iabp.Later that day, the patient developed abdominal pain, which was found on cta to be secondary to arterial thrombi in the right hepatic artery and its proximal branches and in segmental branches of the left kidney, with multiple renal infarcts.On (b)(6)22, the iabp was discontinued due to thrombotic/embolic complications - iabp-related arterial embolism.He also developed loss of distal pulses in the right lower extremity requiring surgery as below.Heparin induced thrombocytopenia was thought to be unlikely after clinical and laboratory assessment.The patient was anticoagulated with bivalrudin.He had worsening acute kidney injury on chronic kidney injury.Another balloon was not used.On (b)(6)23, the patient underwent an embolectomy/thrombectomy of the right leg.On (b)(6)23, a biventricular assist device (bivad) was placed.The patient is currently still admitted".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16407741
• Report Number: 3010532612-2023-00094
• Device Sequence Number: 14880037
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• 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
• Report Date (Section B): 02/06/2023

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: IPN915322
• Device Catalogue Number: IAB-06840-U
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male