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

Model Number	IPN000255
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon (iab) catheter was noted kink during procedure.The iab was unable to be inserted.As a result, the hospital staff open up a new iab catheter and the procedure was successful.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4) the product was not returned for investigation.The reported complaint that the "intra-aortic balloon (iab) catheter was noted kink during procedure" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revised risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) catheter was noted kink during procedure.The iab was unable to be inserted.As a result, the hospital staff open up a new iab catheter and the procedure was successful.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRA 8 IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11928968
• Report Number: 3010532612-2021-00166
• Device Sequence Number: 14539331
• Product Code: DSP
• UDI-Device Identifier: 00801902010759
• UDI-Public: 00801902010759
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 03/31/2022
• Device Model Number: IPN000255
• Device Catalogue Number: IAB-05840-U
• Device Lot Number: 18F20D0027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR