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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FOS

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FOS Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that while in the cath lab the intra-aortic balloon (iab) was inserted via a sheath into the patient's femoral artery. After two hours of intra-aortic balloon pump (iabp) therapy the pump alarmed and according to the (lead) the intra-aortic balloon (iab) was found ruptured upon removal. It is unknown if another intra-aortic balloon (iab) was inserted. The patient outcome is listed as okay. There was no reported patient death, injury, or complications.
 
Manufacturer Narrative
(b)(4). The device was returned to teleflex for analysis. The reported complaint of blood in helium pathway is confirmed. A kink in the teflon sheath and bend to the iab was noted. The cal key and fos were connected to the iabp. The pump status displayed indicated a possible broken fiber. The full length of the fiber was confirmed with no other notable breaks. The iab was leak tested and a full thickness abrasion to the bladder was confirmed and the appearance is consistent with repeated contact with calcified plaque on the aortic wall. A lab inventory guidewire was back loaded and front loaded through the iab. Resistance was noted, but the guidewire was able to advance through the central lumen. No blood or debris was noted. A device history record (dhr) review was conducted with no relevant findings. Teleflex assessed the risk for the reported compliant. There are no new or revised risks.
 
Event Description
It was reported that while in the cath lab the intra-aortic balloon (iab) was inserted via a sheath into the patient's femoral artery. After two hours of intra-aortic balloon pump (iabp) therapy the pump alarmed and according to the (lead) the intra-aortic balloon (iab) was found ruptured upon removal. It is unknown if another intra-aortic balloon (iab) was inserted. The patient outcome is listed as okay. There was no reported patient death, injury, or complications.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of DeviceINTRA- AORTIC BALLOON FOS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville, PA 27560
6104783117
MDR Report Key6199412
MDR Text Key63195079
Report Number1219856-2016-00285
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F16D0049
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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