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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-06830-U
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample not expected to be returned.
 
Event Description
It was reported that the (iab) intra-aortic balloon catheter was inserted in the cath lab. The patient was moved to their room and at an unknown time later it was reported that the iab ruptured. There is no information available about the pump used or alarms. As a result of the rupture the iab was removed and a new iab was inserted successfully. There was no reported patient death, injury or complications. The patient outcome was reported as being good.
 
Manufacturer Narrative
(b)(4) no product was returned for evaluation. A device history record (dhr) 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 reference no. (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 the (iab) intra-aortic balloon catheter was inserted in the cath lab. The patient was moved to their room and at an unknown time later it was reported that the iab ruptured. There is no information available about the pump used or alarms. As a result of the rupture the iab was removed and a new iab was inserted successfully. There was no reported patient death, injury or complications. The patient outcome was reported as being good.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5742437
MDR Text Key47959041
Report Number1219856-2016-00141
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
Remedial Action Recall
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2016
Device Catalogue NumberIAB-06830-U
Device Lot Number18F14E0070
Other Device ID Number00801902003751
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2014
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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