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

Model Number IPN915322

Device Problem Positioning Problem (3009)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Ischemia (1942); Perforation (2001); Cardiogenic Shock (2262); Unspecified Hepatic or Biliary Problem (4493); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event 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.".

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 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
• Type of Device: 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
• MDR Text Key: 309886381
• Report Number: 3010532612-2023-00095
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902161946
• UDI-Public: 10801902161946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1