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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN038102
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Other remarks: see mdr# 3010532612-2020-00363 (b)(4) as the report is related to the same patient.
 
Event Description
It was reported that intra-aortic balloon (iab)was placed into the patient without any problems.The intra-aortic balloon pump (iabp) was started and ran without problems.Six hours later they were called, as blood was noticed in the helium tube.The iabp was stopped immediately, and a new iab was inserted in a new insertion site.The patient's aorta was very calcified, and the doctor decided to insert another iab due to the critical situation of the patient.
 
Manufacturer Narrative
Qn#(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of iab blood in helium pathway is confirmed.Based on the customer photo provided, blood is confirmed within the iab helium pathway/driveline tubing; however, if the product is returned at a later date, a full investigation of the sample will be completed.The root cause of how the blood entered the helium pathway is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00363 (tc 1900080813) as the report is related to the same patient.
 
Event Description
It was reported that intra-aortic balloon (iab)was placed into the patient without any problems.The intra-aortic balloon pump (iabp) was started and ran without problems.Six hours later they were called, as blood was noticed in the helium tube.The iabp was stopped immediately, and a new iab was inserted in a new insertion site.The patient's aorta was very calcified, and the doctor decided to insert another iab due to the critical situation of the patient.
 
Manufacturer Narrative
Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.The intra-aortic balloon catheter (iabc) bladder had a full thickness abrasion, which caused the blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.The root cause of the bladder leak is related to patient condition.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00363 (tc (b)(4)) as the report is related to the same patient.
 
Event Description
It was reported that intra-aortic balloon (iab)was placed into the patient without any problems.The intra-aortic balloon pump (iabp) was started and ran without problems.Six hours later they were called, as blood was noticed in the helium tube.The iabp was stopped immediately, and a new iab was inserted in a new insertion site.The patient's aorta was very calcified, and the doctor decided to insert another iab due to the critical situation of the patient.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10864216
MDR Text Key217080616
Report Number3010532612-2020-00362
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Model NumberIPN038102
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F19F0093
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received08/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NI.; NI.; NI.
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