• 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 SYSTEM, BALLOON, INTRA-AORTIC

  • 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 SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500
Device Problem Pumping Problem (3016)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802)
Event Date 05/15/2017
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the cath lab rn that a patient, while in the cath lab had a cardiac arrest. An intra-aortic balloon (iab) was then placed in the patient. The pump had been supporting the patient well, however, the pump shut down twice but then turned itself back on. The teleflex clinical support specialist spoke with the rn and recommended switching to a different pump, if the issue recurred. The clinical support specialist also instructed the rn to have the pump evaluated by biomed. Teleflex contacted the customer to request additional information and it was reported that the patient expired. Additional efforts were made to obtain information about the event but limited information to teleflex made available for the reported complaint.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for analysis. The hospital biomed checked the pump and could not replicate the issue. Therefore , we are unable to determine the root cause of the reported complaint or confirm the reported complaint. 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. Teleflex will be monitor for developing trends. Other remarks: additional information received july 13, 2017 the teleflex sales specialist met with two registered nurses who managed the patients care. The rn's explained that the pump shut off for 30-60 seconds max. The sales specialist asked them if the pump contributed to the patient outcome. The rn's indicated that they did not believe so as the patient was very sick and had multiple issues, so without a chart review they could not say definitively. Additional information received (b)(6) 2017. A clinical nurse manager stated that it does not appear that the patient's demise had any correlation to the pump malfunction. The chart revealed that the patient coded multiple times upon arrival to the hospital and in the cath lab and was in dire circumstances on arrival to the medical icu.
 
Event Description
It was reported by the cath lab rn that a patient, while in the cath lab had a cardiac arrest. An intra-aortic balloon (iab) was then placed in the patient. The pump had been supporting the patient well, however, the pump shut down twice but then turned itself back on. The teleflex clinical support specialist spoke with the rn and recommended switching to a different pump, if the issue recurred. The clinical support specialist also instructed the rn to have the pump evaluated by biomed. Teleflex contacted the customer to request additional information and it was reported that the patient expired. Additional efforts were made to obtain information about the event but limited information to teleflex made available for the reported complaint.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for analysis. The hospital biomed checked the pump and could not replicate the issue. Therefore , we are unable to determine the root cause of the reported complaint or confirm the reported complaint. 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. Teleflex will be monitor for developing trends. Other remarks: additional information received july 13, 2017 the teleflex sales specialist met with two registered nurses who managed the patients care. The rn's explained that the pump shut off for 30-60 seconds max. The sales specialist asked them if the pump contributed to the patient outcome. The rn's indicated that they did not believe so as the patient was very sick and had multiple issues, so without a chart review they could not say definitively.
 
Event Description
It was reported by the cath lab rn that a patient, while in the cath lab had a cardiac arrest. An intra-aortic balloon (iab) was then placed in the patient. The pump had been supporting the patient well, however, the pump shut down twice but then turned itself back on. The teleflex clinical support specialist spoke with the rn and recommended switching to a different pump, if the issue recurred. The clinical support specialist also instructed the rn to have the pump evaluated by biomed. Teleflex contacted the customer to request additional information and it was reported that the patient expired. Additional efforts were made to obtain information about the event but limited information to teleflex made available for the reported complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAUTOCAT2 WAVE
Type of DeviceSYSTEM, 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 Key6635447
MDR Text Key77391296
Report Number1219856-2017-00121
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
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 Received07/14/2017
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

Patient Treatment Data
Date Received: 06/12/2017 Patient Sequence Number: 1
-
-