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

Model Number IPN039787

Device Problem Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/06/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that while in use the iabp had "frequent possible helium loss 3 alarms".The iab was noted to have a severe kink it in.As a result, a 2nd iab was inserted in the opposite femoral artery.No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that while in use the iabp had "frequent possible helium loss 3 alarms".The iab was noted to have a severe kink it in.As a result, a 2nd iab was inserted in the opposite femoral artery.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint for iab "possible helium loss 3 alarms" was confirmed based on the customer photos provided with the complaint report.The product was not returned for investigation.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The occurrence rate of the reported complaint was within acceptable risk limits.The root cause of the complaint was undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.A full investigation of the sample will be completed, once the product is returned.Other remarks: n/a.Corrected data: n/a.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17240594
• MDR Text Key: 318227828
• Report Number: 3010532612-2023-00365
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902145717
• UDI-Public: 10801902145717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN039787
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F23A0026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 31 KG