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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 Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262)
Event Date 07/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event involved a patient 163cm in height. The (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath. Prior to counterpulsation commencing the 6 inch pressure tubing is connected and after they aspirated back they noticed where the 6 in extension tubing connects to the bifurcation of the catheter was leaking. They tried to tighten the connection and it was still leaking. They removed the 6" extension tubing and connected a stopcock. Then proceeded to aspirate back and hook up the transducer. The patient was sent to the icu. There was no reported patient death, injury or complications. There was no reported delay in iabp therapy. Medical / surgical intervention was not required.
 
Manufacturer Narrative
(b)(4). Returned for evaluation was an extension line typically supplied with the iab kit the iab was not returned for evaluation. Upon initial visual inspection, the extension line appeared typical. The extension line was connected to the central lumen of the bifurcate on a lab inventory iab. The iab was inserted into the t-tube, and the t-tube was pressurized. A leak was immediately noticeable from the extension line. Under microscopic inspection, a crack was noted on the hub of the extension line. This crack likely allowed the extension line to leak, and the appearance of the crack appears consistent with potentially having been over-torqued. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of the extension leaking is confirmed. A crack was found on the extension line hub allowing the hub to leak. The crack appears consistent with potentially having been over-torqued. The root cause of the crack is undetermined. Other remarks:.
 
Event Description
It was reported that the event involved a patient (b)(6)cm in height. The (iab) intra-aortic balloon catheter was inserted via the patient's right femoral artery via a sheath. Prior to counterpulsation commencing the 6 inch pressure tubing is connected and after they aspirated back they noticed where the 6 in extension tubing connects to the bifurcation of the catheter was leaking. They tried to tighten the connection and it was still leaking. They removed the 6" extension tubing and connected a stopcock. Then proceeded to aspirate back and hook up the transducer. The patient was sent to the icu. There was no reported patient death, injury or complications. There was no reported delay in iabp therapy. Medical / surgical intervention was not required.
 
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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 Key5843600
MDR Text Key51128910
Report Number1219856-2016-00163
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Catalogue NumberIAB-06830-U
Device Lot Number18F15A0019
Other Device ID Number00801902003751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2015
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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