MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problem Difficult to Flush (1251)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was unable to aspirate from the port. Therefore the iab was replaced by another device. There was no report of patient death, serious injury or complications.

Manufacturer Narrative

(b)(4). Teleflex received the device for investigation. The reported complaint of iab "unable to aspirate from the port" is not confirmed. Upon return, no damage or abnormalities were noted to the central lumen during visual inspection and functional testing. Although, the root cause of the complaint has remained undetermined the device passed visual and functional test specifications in relation to the reported complaint. 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. The reported complaint 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) was unable to aspirate from the port. Therefore the iab was replaced by another device. There was no report of patient death, serious injury or complications.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8196193
• Report Number: 3010532612-2018-00395
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902034724
• UDI-Public: 00801902034724
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2019
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F17D0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No