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

Catalog Number IAB-06840-U

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) catheter wouldn't pass over the wire.As a result, the iab was not used.Another attempt at the procedure was made with another iab and was successful.There was no delay or interruption in therapy and no patient complications.No reported death or serious injury.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint that the iab "wouldn't pass over the wire" is confirmed.The returned iab was found kinked and the central lumen was broken at this location.A bend was also noted to the central lumen in another location.The damaged central lumen caused guidewire insertion difficulty.A definitive root cause of the bend/kink could not be determined but the damage potentially occurred while removing the iab from the tray.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.This issue will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) catheter wouldn't pass over the wire.As a result, the iab was not used.Another attempt at the procedure was made with another iab and was successful.There was no delay or interruption in therapy and no patient complications.No reported death or serious injury.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• 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: 7190902
• MDR Text Key: 97429065
• Report Number: 1219856-2018-00003
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F16J0019
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1