MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0500

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

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

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The perfusionist called the clinical support specialist (css) and stated they had just inserted a fiberoptic intra-aortic balloon (iab) in a patient in the cath lab.The patient was brought to the operating room and while in the cath lab the fiberoptic would not zero, they switched out consoles and they were able to zero the fiberoptic.The first console will be sent to biomed to have the fiberoptic connection checked.There was no reported death or serious injury or harm to the patient.No medical/surgical intervention was required.There was a report of delay in therapy but no complications causes to the patient.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "fos not recognized" is not able to be confirmed.The root cause of the reported complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.This complaint will be monitored for any developing trends.Other remarks: please refer to mdr #1219856-2017-00163 and (b)(4).

Event Description

The perfusionist called the clinical support specialist (css) and stated they had just inserted a fiberoptic intra-aortic balloon (iab) in a patient in the cath lab.The patient was brought to the operating room and while in the cath lab the fiberoptic would not zero, they switched out consoles and they were able to zero the fiberoptic.The first console will be sent to biomed to have the fiberoptic connection checked.There was no reported death or serious injury or harm to the patient.No medical/surgical intervention was required.There was a report of delay in therapy but no complications causes to the patient.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• 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: 6754364
• MDR Text Key: 81424023
• Report Number: 1219856-2017-00162
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1