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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 Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Communication or Transmission Problem (2896)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 12/31/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the rn that the product was difficult to remove from the package.Before insertion into the patient the fiber optic sensor (fos) and key was inserted into the intra-aortic balloon pump (iabp) but the blue light did not turn green.They then connected the balloon to be used via a transducer line.Once the iabp switched on they discovered blood in the balloon, the catheter was removed and a 30cc fiber-optic intra-aortic balloon (iab) was placed which calibrated fine and worked on wave technology.There was no reported death, serious injury or complications to the patient.Patient outcome was reported as fine.Patient's height: (b)(6).
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of blood in helium pathway is confirmed.Two leaks were confirmed from the bladder membrane; however, it cannot be determined which bladder leak occurred first.The iab was confirmed with a puncture to the bladder, consistent with contact from the broken fiber, which was found near the distal tip of the iab.Additionally, the iab was confirmed with another leak from the bladder membrane near the distal tip, and the damage is consistent with contact from a sharp or broken fiber.The root cause of the broken fiber 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.A nonconformance has been initiated to further investigate the cause of the issue.
 
Event Description
It was reported by the rn that the product was difficult to remove from the package.Before insertion into the patient the fiber optic sensor (fos) and key was inserted into the intra-aortic balloon pump (iabp) but the blue light did not turn green.They then connected the balloon to be used via a transducer line.Once the iabp switched on they discovered blood in the balloon, the catheter was removed and a 30cc fiber-optic intra-aortic balloon (iab) was placed which calibrated fine and worked on wave technology.There was no reported death, serious injury or complications to the patient.Patient outcome was reported as fine.Patient's height: (b)(6).
 
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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
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 Key7225279
MDR Text Key98637761
Report Number3010532612-2018-00001
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2018
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18S16K0026
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2017
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 Age75 YR
Patient Weight75
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