MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Blood Loss (2597)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4). For reported complaint involving the same patient and device see mdr #3010532612-2019-00108 and (b)(4).

Event Description

It was reported that after intra-aortic balloon (iab) treatment, the sheath was removed successfully. The wall of the sheath was found damaged. The patient outcome was reported as fine. Additional information obtained. There was no report of removal difficulty during the sheath removal process. The sheath was found broken after finishing the treatment. It was also reported that the patient was injured. The patient lost much blood (about 200ml) as the un-smooth insertion. Additional information obtained. There were no adverse events from the blood loss. The patient did not require a blood transfusion, blood pressure did not decline and no reported increase in chest pain. There was no report of patient death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 8497258
• MDR Text Key: 141386597
• Report Number: 3010532612-2019-00119
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2019
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17M0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial