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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when the doctor try to insert the intra-aortic balloon (iab) difficulties were encountered.The doctor then removed the balloon and found that the balloon was already detached from the catheter body.As a result, the doctor performed the procedure without the iab therapy.There was no report of patient complications, serious injury or death.Additional information was received.The iab catheter was not so smooth when entering introducer sheath from tip to 1/3 distal.Yes, the iab withdrawn through the sheath.There are 2 parts of iab catheter here, first is the balloon second is inner lumen catheter (body catheter) usually balloon and body catheter are intact but not this one.No surgical intervention required because balloon is not fully entered the body (still in sheath).No adverse event, patient require increase in hospitalization but not due to this incident.
 
Event Description
It was reported that when the doctor try to insert the intra-aortic balloon (iab) difficulties were encountered.The doctor then removed the balloon and found that the balloon was already detached from the catheter body.As a result, the doctor performed the procedure without the iab therapy.There was no report of patient complications, serious injury or death.Additional information was received.The iab catheter was not so smooth when entering introducer sheath from tip to 1/3 distal.Yes, the iab withdrawn through the sheath.There are 2 parts of iab catheter here, first is the balloon second is inner lumen catheter (body catheter) usually balloon and body catheter are intact but not this one.No surgical intervention required because balloon is not fully entered the body (still in sheath).No adverse event, patient require increase in hospitalization but not due to this incident.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab balloon damaged is confirmed.During the investigation, a leak was noted from the bladder membrane at the distal tip.The bladder was damaged, and the damage is likely a result of customer handling during product prep.No other leaks were detected during functional testing.Though the root cause of the damaged bladder is undetermined, the damage is most likely a result from customer handling during product prep/removal from the tray.An in-service will be performed to reiterate the instructions for use (ifu) to the customer.The complaint is isolated.The returned packaging tray was damaged with evidence that the ifu was not followed to properly remove the device from its packaging.Improper removal of the device will result in damage to the device.The instructions for use states "1.Connect one-way valve to male luer on short driveline tubing attached to iab.Insert supplied syringe into one-way valve.Slowly aspirate a full syringe of air.Precaution: the one-way valve will maintain vacuum on the balloon and must remain in place until is fully inserted.Remove syringe.2.Remove catheter from tray, keeping it in line with balloon membrane.3.Grasp catheter close to tray and pull it straight out of the holding sleeve.Note: keep catheter level with tray.Do not lift or bend during removal." 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 risk.This will be monitored for any developing trends.
 
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Brand Name
ULTRAFLEX IAB: 7.5FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8675692
MDR Text Key147226155
Report Number3010532612-2019-00181
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2020
Device Catalogue NumberIAB-06830-U
Device Lot Number18F18C0033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Date Manufacturer Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight55
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