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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA-AORTIC BALLOON FIBER OPTIC SYS
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA-AORTIC BALLOON FIBER OPTIC SYS Back to Search Results
Catalog Number IAB-05830-LWS
Device Problems Disconnection (1171); Failure to Zero (1683)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the cath lab manager that while inserting an intra-aortic balloon (iab) via a sheath into a female patient the catheter would not zero.As they inspected the catheter further they realized that the yellow cord on the fiber optic catheter was not connected to the blue connector.The iab was inserted via the left femoral artery and was removed.Another catheter was inserted via the same insertion site.There was a delay in therapy of a few minutes.There was no reported death, injuries, or complications.Patient outcome is listed as survived.
 
Manufacturer Narrative
(b)(4).Device evaluation: returned for evaluation was a 30cc 8.0fr iab fiberoptix sensor (fos) assembly.The bladder membrane was fully unwrapped.A small area of dried blood was noted on the outside of the bladder membrane near the distal tip.No blood was noted within the bladder membrane.The one-way valve was returned connected to the inflation lumen.The 30cc driveline tubing typically supplied with the iab kit was also returned for evaluation.The clamshell housing was noted separated from the fos.The fos connector and cal key were examined.The gray fos connector was completely disengaged from the blue clamshell housing and both retaining tabs were absent.The cal key appeared fully intact with no damage.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The gray fos connector was inserted into the pump without the clamshell housing and was able to be zeroed.The pump displayed an "ok" status.The fiber was fully intact.The iab was submerged in water and leak tested.No holes or leaks were detected.Full inflation was achieved.The unit passed leak test.See other remarks section for continuation.Other remarks: a device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the clamshell housing was separated is confirmed by visual inspection of the device.(b)(4) concluded no corrective actions were required on may 20, 2015.The device was manufactured prior to the closing date of the nc investigation.The root cause of the separation is undetermined.
 
Event Description
It was reported by the cath lab manager that while inserting an intra-aortic balloon (iab) via a sheath into a female patient the catheter would not zero.As they inspected the catheter further they realized that the yellow cord on the fiber optic catheter was not connected to the blue connector.The iab was inserted via the left femoral artery and was removed.Another catheter was inserted via the same insertion site.There was a delay in therapy of a few minutes.There was no reported death, injuries, or complications.Patient outcome is listed as survived.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of Device
INTRA-AORTIC BALLOON FIBER OPTIC SYS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5205531
MDR Text Key30715378
Report Number1219856-2015-00234
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 company representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2016
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18F14M0033
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age56 YR
Patient Weight135
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