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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 Entrapment of Device (1212)
Patient Problem Vascular Dissection (3160)
Event Date 12/23/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of removal difficulty is confirmed. The iab was returned with a damaged bladder consistent with removal difficulty. During the investigation, blood was confirmed within the iab helium pathway. The blood found within the bladder membrane could have potentially led to removal difficulties through entrapment. Due to the damaged state of the iab upon return, the original cause of the leak was unable to be determined. The root cause of how blood entered the helium pathway is undetermined. A device history record (dhr) review was conducted for the lot number/serial 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. This will be monitored for developing trends. No further action at this time.
 
Event Description
It was reported that upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck. The md pulled on the catheter and the patient suffered a femoral tear. The patient was operated on and he is currently doing fine. Once the balloon was removed, it was noticed that inside the balloon was foreign substances. Medical intervention was required to repair the femoral tear. There was no reported patient death.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck. The md pulled on the catheter and the patient suffered a femoral tear. The patient was operated on and he is currently doing fine. Once the balloon was removed, it was noticed that inside the balloon was foreign substances. Medical intervention was required to repair the femoral tear. There was no reported 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 Key7180390
MDR Text Key113672438
Report Number1219856-2018-00012
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17C0040
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2017
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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