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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
Catalog Number IAB-05840-LWS
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2018
Event Type  malfunction  
Manufacturer Narrative
Continuation of concomitant products: entilator. (b)(4).
 
Event Description
It was reported by the staff that the intra-aortic balloon (iab) side-port of the sheath was clotted off. As a result, the staff observed the timing on the side monitor. There was no report of delay in therapy. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
Concomitant medical products: (b)(4). Teleflex did not receive the device for investigation. The reported complaint of iab ap waveform poor signal is confirmed based on the customer pictures provided with the complaint report. 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. An in-service was performed to reiterate the ifu. The reported complaint will be monitored for any developing trends. If the product is returned at a later date, a full investigation of the sample will be completed.
 
Event Description
It was reported by the staff that the intra-aortic balloon (iab) side-port of the sheath was clotted off. As a result, the staff observed the timing on the side monitor. There was no report of delay in therapy. There was no report of patient complication or serious injury and death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7796767
MDR Text Key117575175
Report Number3010532612-2018-00263
Device Sequence Number1
Product Code DSP
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,health
Type of Report Initial,Followup
Report Date 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17G0001
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/20/2018 Patient Sequence Number: 1
Treatment
VASOPRESSIN, MILRINONE, EPINEPHRINERESPIRATORY V; VASOPRESSIN, MILRINONE, EPINEPHRINERESPIRATORY V; VASOPRESSIN, MILRINONE, EPINEPHRINERESPIRATORY V
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