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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
Model Number IPN000254
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a clinical support specialist (css) that she received a call directly from biomed stating that he had an intra-aortic balloon pump (iabp) in the shop since christmas eve and the nurses reported blood back.Biomed stated that he does not think the incident has been reported to teleflex and he doesn't think the nurses saved the catheter.Biomed does not have any information and doesn't know which unit the patient was in.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab blood in helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
Event Description
It was reported by a clinical support specialist (css) that she received a call directly from biomed stating that he had an intra-aortic balloon pump (iabp) in the shop since christmas eve and the nurses reported blood back.Biomed stated that he does not think the incident has been reported to teleflex and he doesn't think the nurses saved the catheter.Biomed does not have any information and doesn't know which unit the patient was in.
 
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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
MDR Report Key9858834
MDR Text Key184661537
Report Number3010532612-2020-00065
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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