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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 30CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 30CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-04830-U
Device Problems Entrapment of Device (1212); Fluid Leak (1250)
Patient Problems Ischemia (1942); Thrombus (2101); Vascular System (Circulation), Impaired (2572)
Event Date 10/31/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that blood was in the helium circuit of the balloon. It was impossible to remove the balloon which was locked inside the left common femoral artery. The clinical consequence was ischemia of the lower left limb. Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream. The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.
 
Manufacturer Narrative
(b)(4). Additional information received the iab therapy was in use for 24 hours prior the nurse noticing the blood. The pump was stopped and blood did not enter it. Evaluation: teleflex received the device for analysis. A manual pump was attached to the iab upon receipt. The short driveline tubing was retro fitted to connect the manual pump to the iab with a standardized connector. The connector that allows the driveline tubing to connect to the iab short driveline tubing was not returned with the device. The one-way valve was not returned for evaluation. Hard blood clots were noted within the bladder membrane upon return. The bladder appeared torn approximately 13. 0cm from the distal tip of the catheter. The bladder thickness was measured and was within specification. 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. Teleflex assessed the risk for the reported complaint and determined that the occurrence rate is within acceptable risk limits. See other remarks section. Other remarks: conclusion: the reported complaint of blood in the helium pathway is confirmed based on visual inspection of the device. Three cuts consistent with contact from a sharp object were found on the bladder membrane allowing blood to enter the helium pathway. No abrasions were noted. The root cause of the damage is undetermined.
 
Event Description
It was reported that blood was in the helium circuit of the balloon. It was impossible to remove the balloon which was locked inside the left common femoral artery. The clinical consequence was ischemia of the lower left limb. Emergency surgery was performed to remove the balloon and repair the left common femoral artery and fogarty thrombectomy by the superficial femoral downstream. The staff noticed that the balloon contained very hard blood clots that prevented the deflation of the balloon.
 
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Brand NameNARROWFLEX IAB: 8FR 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 Key6109222
MDR Text Key60110504
Report Number1219856-2016-00263
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K993966
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 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Catalogue NumberIAB-04830-U
Device Lot Number18F16D0024
Other Device ID Number00801902002631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2016
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: 11/17/2016 Patient Sequence Number: 1
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