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

Catalog Number	IAB-06830-U
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after the placement of the 30cc intra-aortic balloon catheter (iabc), the user found that the patient's build is too big for the catheter and tried to remove it.However, it was noted that the catheter got stuck in the sheath and the doctor had to remove the iab together with the sheath.A 40cc catheter was inserted in the patient.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the "catheter got stuck in the sheath" 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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that after the placement of the 30cc intra-aortic balloon catheter (iabc), the user found that the patient's build is too big for the catheter and tried to remove it.However, it was noted that the catheter got stuck in the sheath and the doctor had to remove the iab together with the sheath.A 40cc catheter was inserted in the patient.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9405478
• Report Number: 3010532612-2019-00424
• Device Sequence Number: 19552537
• Product Code: DSP
• UDI-Device Identifier: 00801902010742
• UDI-Public: 00801902010742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 11/30/2019
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F17M0006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1