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

Catalog Number IAB-05840-LWS

Device Problem Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fiber optic sensor (fos) balloon did not work (it did not detect the optical fiber).As a result, another catheter without optical fiber was used and it worked only in pressure.The problem was encountered when inserting and extracting the connector.The pump alarmed: fiber optic sensor not detected.Patient presented with an acute myocardial infarction and a cardiac arrest.A death was reported but per dr.(b)(6), head of the department the device did not contribute to the patient's death.

Manufacturer Narrative

Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "did not detect" the fos is confirmed.Although, the root cause of the recessed fos 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 of the issue.The complaint will be monitored for any developing trends.This issue will be monitored for any developing trends.

Event Description

It was reported that the fiber optic sensor (fos) balloon did not work (it did not detect the optical fiber).As a result, another catheter without optical fiber was used and it worked only in pressure.The problem was encountered when inserting and extracting the connector.The pump alarmed: fiber optic sensor not detected.Patient presented with an acute myocardial infarction and a cardiac arrest.A death was reported but per (b)(6), head of the department the device did not contribute to the patient's death.

• 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: 6823780
• MDR Text Key: 83854524
• Report Number: 1219856-2017-00190
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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: 06/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S16F0025
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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