MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the intra-aortic balloon pump (iabp) alarmed message saying, "kinked catheter".When the rn looked at the insertion site and followed the tubing to find any source for the alarm, blood suddenly appeared in the helium/drive line.As a result, the rn immediately clamped the helium line and stat paged cardiology team.The intra-aortic balloon (iab) was removed by cardiology team as soon as possible.There was no patient death reported.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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 Description

It was reported the intra-aortic balloon pump (iabp) alarmed message saying, "kinked catheter".When the rn looked at the insertion site and followed the tubing to find any source for the alarm, blood suddenly appeared in the helium/drive line.As a result, the rn immediately clamped the helium line and stat paged cardiology team.The intra-aortic balloon (iab) was removed by cardiology team as soon as possible.There was no patient death reported.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8184816
• MDR Text Key: 131029857
• Report Number: 3010532612-2018-00394
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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 Catalogue Number: IAB-06840-U
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1