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

Model Number	IPN000255
Medical Device Problem Code	Failure to Reset (1532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) was placed, the cal key read "defective".The user tried to take it out and clean it off, replace, flip over, etc.But could not clear that alarm.As a result, the physician removed the catheter and considered another catheter but then went with the impella device instead.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) was placed, the cal key read "defective".The user tried to take it out and clean it off, replace, flip over, etc.But could not clear that alarm.As a result, the physician removed the catheter and considered another catheter but then went with the impella device instead.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab cal key difficulty is not confirmed.The cal key and fos connection of the returned iabc were intact and functioned properly when connected to a pump.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.Additionally, unrelated to the reported complaint the returned iabc bladder was found withdrawn through the teflon sheath and buckling was noted to the teflon sheath extrusion.This indicates the iabc was not removed correctly per the instruction for use (ifu).An in-service has been requested to reiterate the appropriate method for iabc removal.A device history record (dhr) review was not performed.There was no confirmed product failure with the returned sample.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12143826
• Report Number: 3010532612-2021-00185
• Device Sequence Number: 3819723
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 02/28/2023
• Device Model Number: IPN000255
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21C0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.