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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06840-U
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that an intra-aortic balloon (iab) was placed in a patient of 164cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for analysis.The reported complaint of catheter stuck in sheath is not confirmed.The teflon sheath was removed from the iab without any damage found to the iab or any potential causes for difficulty.Both the sheath and iab bladder passed dimensional specifications.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.The reported complaint will be monitored for any developing trends.
 
Event Description
It was reported that an intra-aortic balloon (iab) was placed in a patient of (b)(6)cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6677268
MDR Text Key78705065
Report Number1219856-2017-00137
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/07/2017
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 Date03/31/2019
Device Catalogue NumberIAB-06840-U
Device Lot Number18F17C0016
Other Device ID Number00801902026804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/07/2017
Initial Date FDA Received06/29/2017
Supplement Dates Manufacturer Received08/02/2017
Supplement Dates FDA Received08/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2017
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 Age80 YR
Patient Weight74
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