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

Catalog Number	IAB-05840-U
Medical Device Problem Codes	Device Alarm System (1012); Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4) full udi not available as the lot# was not provided by the customer.
Event or Problem Description
It was reported that: "iab hub disconnected from sterile covering, dripping noise from iab.Initial call to hotline at 2138 for "dripping noise" from iab.Therapy appropriate, no blood or condensation in driveline.Condensation drain emptied and driveline purged with no change.2200 xray verified placement.Noise stops when therapy paused.No known valve issues i.E.Insufficiency, stenosis.No recent echo available.No known aneurysms.Visualized mucus buildup in inline ett suction and recommended clearing the line.No further reports of the noise from the iab.Additional call at 0630 (b)(6) 2024 d/t helium alarms.By 0630, reported noise no longer audible.Staff experiencing repeated helium loss 2 and 3 alarms within seconds of attempting to resume iabp therapy.On facetime, patient's hip remains hyperextended.No blood in driveline.Bpw appears squared off.Per the rn, there were occasional helium alarms prior to the patient's bath, but alarms became "nearly constant" afterwards.Kyle mentioned the iab appeared low on the xray from (b)(6) morning.I asked to see the iab site and visualized the hub had disconnected from the sterile covering and been pulled distally.Staff was unable to recall when that had occurred.We discussed the iab would no longer be sterile to allow for repositioning and was likely the cause for the alarms at this time.Removal recommended.Iab was removed without incident." additional information: " they did end up placing a new iab via the left femoral today 09oct2024 at approximately 1200 cst.Patient tolerated well, no complications reported with the insertion.".
Event or Problem Description
It was reported that: "iab hub disconnected from sterile covering, dripping noise from iab.Initial call to hotline at 2138 for "dripping noise" from iab.Therapy appropriate, no blood or condensation in driveline.Condensation drain emptied and driveline purged with no change.2200 xray verified placement.Noise stops when therapy paused.No known valve issues i.E.Insufficiency, stenosis.No recent echo available.No known aneurysms.Visualized mucus buildup in inline ett suction and recommended clearing the line.No further reports of the noise from the iab.Additional call at 0630 9oct2024 d/t helium alarms.By 0630 , reported noise no longer audible.Staff experiencing repeated helium loss 2 and 3 alarms within seconds of attempting to resume iabp therapy.On facetime, patient's hip remains hyperextended.No blood in driveline.Bpw appears squared off.Per the rn, there were occasional helium alarms prior to the patient's bath, but alarms became "nearly constant" afterwards.Kyle mentioned the iab appeared low on the xray from 09oct morning.I asked to see the iab site and visualized the hub had disconnected from the sterile covering and been pulled distally.Staff was unable to recall when that had occurred.We discussed the iab would no longer be sterile to allow for repositioning and was likely the cause for the alarms at this time.Removal recommended.Iab was removed without incident." additional information: " they did end up placing a new iab via the left femoral today (b)(6) 2024 at approximately 1200 cst.Patient tolerated well, no complications reported with the insertion.".
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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20596912
• Report Number: 3010532612-2024-00925
• Device Sequence Number: 6528459
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: (01)00801902010759(11)240223(17)260131(10)18F24B0051(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/08/2024

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: 01/31/2026
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F24B0051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 77 KG