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 Death (1802)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Teleflex received the device for analysis.The reported complaint of "fos did not zero" is confirmed.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.The root cause of the recessed fos 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 risks.This complaint will be monitored for any developing trends.Other remarks: reference mfr.Report #1219856-2017-00079 - arrow complaint ref.#(b)(4).

Event Description

It was reported that while in the cath lab prior to insertion that the fiber optic did not zero.A second catheter did zero but became contaminated.A third catheter did not zero and was not recognized on the hospitals pumps.There was a report of delay in therapy.There was a reported death but per the healthcare professional the device did not contribute to the patient's death.

• 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: 6647779
• MDR Text Key: 77843403
• Report Number: 1219856-2017-00143
• 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
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0025
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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
• Patient Age: 85 YR