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

Catalog Number IAB-05840-LWS

Device Problems Failure to Zero (1683); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: for related complaint refer to: mdr #1219856-2017-00221 and (b)(4).

Event Description

It was reported by the lead technician that they have a patient in the cath lab they just inserted a fiber optic sensor intra-aortic balloon (fos iab) and the two audible tones were not given when the fos was connected.Upon inspection, the tip is below the housing in the fos connector.As a result, the iab was removed and replaced with another iab.The patient was in poor condition upon arrival to the cath lab.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "the tip is below the housing in the fos connector" is confirmed.Although, the root cause of the complaint is undetermined the fos was returned with a recessed connector; therefore, a light path could not be established between the sensor and the pump.The fiber was found intact and functional.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.A nonconformance has been initiated to further investigate the cause.Other remarks: for related complaint refer to: (b)(4).

Event Description

It was reported by the lead technician that they have a patient in the cath lab they just inserted a fiber optic sensor intra-aortic balloon (fos iab) and the two audible tones were not given when the fos was connected.Upon inspection, the tip is below the housing in the fos connector.As a result, the iab was removed and replaced with another iab.The patient was in poor condition upon arrival to the cath lab.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6927847
• MDR Text Key: 89823872
• Report Number: 1219856-2017-00220
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2017
• 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-05840-LWS
• Device Lot Number: 18F16J0043
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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