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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 IPN000254
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded, and completed the surgery.There was no report of patient complications serious injury, or death.
 
Event Description
It was reported that when the intra-aortic balloon (iab) was in use, it was noticed by the staff that there was a blood leakage through the anti-reflux valve on the introducer sheath.It was unknown how the issue was resolved; the doctors proceeded and completed the surgery.There was no report of patient complications serious injury or death.
 
Manufacturer Narrative
(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of sheath valve leak in use 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 Key10879485
MDR Text Key218011916
Report Number3010532612-2020-00371
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,distri
Type of Report Initial,Followup
Report Date 11/16/2020
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 Date05/31/2022
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20F0016
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received11/20/2020
Supplement Dates Manufacturer Received12/10/2020
Supplement Dates FDA Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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