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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 Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation; therefore, the reported complaint that the "balloon was not intact" 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 revised risks. The reported complaint will be monitored for any developing trends. No further action required at this time. Other remarks: re: medwatch report # (b)(4). Teleflex received an mdr from fda (ref: (b)(4)) on 2/20/2019. At the time of receipt, we reviewed the information and conducted a search of our complaint tracking system that showed a match of a similar complaint that was already received, including the same account information with similar event details, which also occurred on the same month date. At that time we linked and attached the mdr from fda to the existing complaint in our system, ref: teleflex # (b)(4). During further evaluation of the complaint details, we recognized the complaint did not correctly match the information reported on the mdr from fda. Once we realized the error, we removed the mdr reference from the complaint (ref: teleflex # (b)(4)) and immediately opened a new complaint to link the mdr to a new complaint (ref: teleflex # (b)(4)). For this reason, we are submitting the initial mdr late. This is considered to be an isolated incident due to human error. (b)(4), post market surveillance manager contacted fda (1-888-info-fda (1-888-463-6332) to explain the situation that occurred. The fda stated that the error should be explained on the late mdr submitted and within the complaint file.
 
Event Description
It was reported that the event occurred during a cardiac catherization. When the intra-aortic balloon (iab) was removed, it was noted by the staff that the balloon was not intact. The patient received a coronary stent and the procedure was very successful. There was no report of patient 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
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key8565678
MDR Text Key144155928
Report Number3010532612-2019-00139
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/03/2017
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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