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

Model Number IPN000254

Device Problem Failure to Zero (1683)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the clinical support specialist (css) that the fos was zeroed prior to insertion.When the intra-aortic balloon (iab) was placed there was no signal from the fos.As a result, the iab was removed and another one was inserted.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).The product was not returned for investigation.The reported complaint of iab "no signal from the fos" is not able to be confirmed.The product was not returned for investigation.If the product is returned at a later date, a full investigation of the sample will be completed.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 risk.This will be monitored for any developing trends.

Event Description

It was reported by the clinical support specialist (css) that the fos was zeroed prior to insertion.When the intra-aortic balloon (iab) was placed there was no signal from the fos.As a result, the iab was removed and another one was inserted.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• 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: 12091810
• MDR Text Key: 259364516
• Report Number: 3010532612-2021-00171
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

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: 07/31/2022
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20H0050
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1