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	Dyspnea (1816); Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942); Perforation (2001); Cardiogenic Shock (2262); Unspecified Hepatic or Biliary Problem (4493); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
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, "on (b)(6) 2022, she presented to tmc with subacute worsening dyspnea on exertion and was found to be in acute on chronic hfref which progressed to cardiogenic shock.On (b)(6) 2022, an ultra flex 7f 40cc iabp was placed femorally.The patient was anticoagulated with heparin gtt with therapeutic anti-xa and was kept on 1:1 iabp.On (b)(6) 2022, she developed acute limb ischemia of both feet due to thromboemboli thought to be coming from the iabp.She was also found to have multiple splenic infarcts and bilateral renal infarcts.She also had severe transient hepatic failure right after iabp which retrospectively might have been related to embolic phenomenon to the liver.Iabp removed and she was placed on va ecmo.Unfortunately, her course was complicated by severe gastrointestinal bleeding and gallbladder perforation making her not a surgical candidate for biventricular assist device surgery.The patient was transitioned to comfort measures only.On (b)(6) 2022, the patient expired.".
Additional Manufacturer Narrative
(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.
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, "on 8/3/22, she presented to tmc with subacute worsening dyspnea on exertion and was found to be in acute on chronic hfref which progressed to cardiogenic shock.On (b)(6) 2022, an ultra flex 7f 40cc iabp was placed femorally.The patient was anticoagulated with heparin gtt with therapeutic anti-xa and was kept on 1:1 iabp.On 8/22/22, she developed acute limb ischemia of both feet due to thromboemboli thought to be coming from the iabp.She was also found to have multiple splenic infarcts and bilateral renal infarcts.She also had severe transient hepatic failure right after iabp which retrospectively might have been related to embolic phenomenon to the liver.Iabp removed and she was placed on va ecmo.Unfortunately, her course was complicated by severe gastrointestinal bleeding and gallbladder perforation making her not a surgical candidate for biventricular assist device surgery.The patient was transitioned to comfort measures only.On (b)(6) 2022, the patient expired.".

• 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: 16407898
• Report Number: 3010532612-2023-00095
• Device Sequence Number: 17723864
• 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: Unknown