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

Model Number IPN000254

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded, and completed the surgery.There was no report of patient complications serious injury, or death.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded and completed the surgery.There was no report of patient complications serious injury or death.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of sheath valve leak in use 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: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10879485
• MDR Text Key: 218011916
• Report Number: 3010532612-2020-00371
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20F0016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1