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

Catalog Number IAB-05840-LWS

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos).There was no patient interaction.Additional information received: the rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab.The fos failed to register and as a result, another iab was used.There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of fos would not zero is confirmed.Although, the root cause of the fos fiber being broken could not be determined the light path could not be established between the sensor and the pump.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 issue will be monitored for any developing trends.

Event Description

It was reported that the event involved a fiberoptic intra-aortic balloon (iab) that failed to register the fiber optic sensor (fos).There was no patient interaction.The rn stated that the event took place in the cath lab and occurred prior to the insertion of the iab.The fos failed to register and as a result, another iab was used.There was a delay of ten minutes but no patient complications and no medical/surgical intervention required.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 6757351
• MDR Text Key: 81509658
• Report Number: 1219856-2017-00177
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17C0058
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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