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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA-AORTIC BALLOON Back to Search Results
Catalog Number IAB-06840-U
Device Problem Fluid Leak (1250)
Patient Problems Unspecified Infection (1930); Myocardial Infarction (1969)
Event Date 11/19/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Sample will not be returned for evaluation.
 
Event Description
It was reported that on (b)(6) 2015 at 17:00 while in the cath lab, the intra-aortic balloon (iab) catheter was inserted using a teflon sheath via the femoral artery and the intra-aortic balloon pump (iabp) therapy began. The patient received approximately two hours of iabp therapy and then was transferred to the operating room for an emergency operation. While in the operating room, the pump was replaced by a competitor's pump. After replacement of the pump, alarm went off and blood in line was confirmed. The iab was removed and replaced in the opposite femoral artery. There was no reported patient death, or complications. Medical/surgical intervention was not required. There was a one hour delay in iabp therapy however, the interruption did not cause harm to the patient. The patient outcome is good.
 
Manufacturer Narrative
(b)(4). Evaluation: no product was returned for evaluation. A device history record review was conducted for the lot number/serial number with one relevant finding. The component was manufactured prior to the field correction action recall for sheath hub separation (capa (b)(4)). The reported complaint was not related to this issue. Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined.
 
Event Description
It was reported that on (b)(6) 2015 at 17:00 while in the cath lab, the intra-aortic balloon (iab) catheter was inserted using a teflon sheath via the femoral artery and the intra-aortic balloon pump (iabp) therapy began. The patient received approximately two hours of iabp therapy and then was transferred to the operating room for an emergency operation. While in the o. R. , the pump was replaced by a competitor's pump. After replacement of the pump, alarm went off and blood in line was confirmed. The iab was removed and replaced in the opposite femoral artery. There was no reported patient death, or complications. Medical/surgical intervention was not required. There was a one hour delay in iabp therapy however, the interruption did not cause harm to the patient. The patient outcome is good.
 
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Brand NameULTRAFLEX IAB: 7.5FR 40CC
Type of DeviceINTRA-AORTIC BALLOON
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5547215
MDR Text Key41854116
Report Number1219856-2016-00083
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K000729
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 03/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2016
Device Catalogue NumberIAB-06840-U
Device Lot Number18F14J0027
Other Device ID Number00801902026804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2016 Patient Sequence Number: 1
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