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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the arterial sheath was inserted successfully, but the spring-wire guide (swg) was not delivered smoothly. The angle of the sheath was adjusted, but the swg was still not delivered smoothly. As a result, the swg and the catheter were inserted slowly. The process of usage and removal of the sheath were successful. Patient outcome reported as fine. There was no report of patient death.
 
Manufacturer Narrative
(b)(4). For reported complaint involving the same patient and device see mdr #3010532612-2019-00119 and (b)(4). Teleflex received the device for investigation. The reported complaint that the "spring-wire guide was not delivered smoothly" is confirmed. A broken central lumen was noted on the returned iab during the complaint investigation, and this is consistent with guidewire insertion difficulty. The root cause of the broken central lumen is undetermined but a potential cause is a result of improper customer handling during preparation and insertion of the iab. 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 assessed the risk for the reported complaint. There are no new or revised risks. The reported complaint will be monitored for any developing trends. An in-service will be performed to reiterate the ifu to the customer. Other remarks: additional information received. There was no reported difficulty with insertion of the spring wire guide.
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the arterial sheath was inserted successfully, but the spring-wire guide (swg) was not delivered smoothly. The angle of the sheath was adjusted, but the swg was still not delivered smoothly. As a result, the swg and the catheter were inserted slowly. The process of usage and removal of the sheath were successful. Patient outcome reported as fine. There was no report of patient death.
 
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Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8496900
MDR Text Key141376938
Report Number3010532612-2019-00108
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberIAB-06830-U
Device Lot Number18F17M0006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No

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