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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 Problems Injury (2348); Vascular System (Circulation), Impaired (2572)
Event Date 08/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of removal difficulty is confirmed. Dried blood was found on the interior of the iab bladder membrane, consistent with contact from the broken fiber near the distal tip of the iab. Although, a definitive root cause of the broken fiber could not be determined. 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 has assessed the risk for the reported complaint. There are no new or revised risks. A nonconformance has been initiated to further investigate the root cause. Other remarks: evaluation codes: (b)(4).
 
Event Description
It was reported that there was difficulty encountered during the removal of the catheter. Vascular surgery was needed to remove the intra-aortic balloon (iab). Once the catheter was removed, granules were seen inside the balloon. The femoral flow was compromised. Medical/surgical intervention was required. There was no reported patient death.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there was difficulty encountered during the removal of the catheter. Vascular surgery was needed to remove the intra-aortic balloon (iab). Once the catheter was removed, granules were seen inside the balloon. The femoral flow was compromised. Medical/surgical intervention was required. 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.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6786219
MDR Text Key111087488
Report Number1219856-2017-00191
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 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17B0011
Other Device ID Number00801902007247
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
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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