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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 IPN039787
Device Problem Material Rupture (1546)
Patient Problem Death (1802)
Event Date 12/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after the insertion of the intra-aortic balloon (iab) the balloon ruptured 2 hours after.As a result, the iab was replaced and the same insertion site was used.A patient death occurred and the attending physician (lambros karagounis) made the medical judgement that the device did not cause or contribute to the patient's death.
 
Event Description
It was reported that after the insertion of the intra-aortic balloon (iab) the balloon ruptured 2 hours after.As a result, the iab was replaced and the same insertion site was used.A patient death occurred and the attending physician (lambros karagounis) made the medical judgement that the device did not cause or contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint that the "balloon ruptured" is not able to be confirmed.The root cause of the complaint 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.
 
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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 Key11147015
MDR Text Key226026316
Report Number3010532612-2021-00011
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberIPN039787
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20B0037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/22/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
Patient Weight95
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