MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-05830-U
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the intra-aortic balloon (iab) was inserted into the patient's right femoral artery through the sideport sheath without difficulty.When the iab was inflated it was noted that the iab would not fully inflate.As a result, the iab was removed and a second iab was used on the patient.After the iab was removed, the tech connected the iab to another intra-aortic balloon pump (iabp) and heard air coming out.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported the intra-aortic balloon (iab) was inserted into the patient's right femoral artery through the sideport sheath without difficulty.When the iab was inflated it was noted that the iab would not fully inflate.As a result, the iab was removed and a second iab was used on the patient.After the iab was removed, the tech connected the iab to another intra-aortic balloon pump (iabp) and heard air coming out.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn#: (b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab leak suspected is not able to be confirmed.The root cause of the complaint is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.

• Brand Name: ULTRA 8 IAB: 8FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9460752
• Report Number: 3010532612-2019-00448
• Device Sequence Number: 3103337
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• 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): 11/22/2019

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: 06/30/2021
• Device Catalogue Number: IAB-05830-U
• Device Lot Number: 18F19G0020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1