• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
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). 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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-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 Key6754364
MDR Text Key246237329
Report Number1219856-2017-00162
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2017
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 Unkown

-
-