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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 Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/09/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was been reported via a hotline call to the clinical support specialist (css). The registered nurse (rn) in the cardiovascular recovery is calling to report possible helium loss alarm and specks of blood in the driveline. The first alarm was noted approx. 20 min prior to the css calling the rn back. The patient is 62 inches with a 30cc iab. The rn confirmed there are specks of blood in the driveline. The css instructed the rn to clamp the gas tubing, disconnect from the pump and have the iab removed within 30 min and save for return. The pa/np is at the bedside to pull the iab currently and they are not planning to insert another. According to the rn they will support the patient with vasoactive drips. No further questions for the css at this time. Length of iabp therapy prior to event: ~ 13 hours.
 
Manufacturer Narrative
(b)(4). Returned for evaluation was a 7. 5fr 30cc iab with its supplied return kit. The driveline tubing typically supplied with the iab kit was also returned. The 30cc connector was not returned connected to the driveline tubing. The driveline tubing was connected to the short driveline tubing. The ap pressure line was connected to the central lumen at the bifurcate. Blood was noted within the bladder membrane. The distal end of the teflon sheath was located approximately 24. 0cm from the distal tip of the catheter. No kinks were noted on the device. The bladder thickness was measured at six points with measurements within specification. The one-way valve was tested and passed. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times. The iab was submerged in water and leak tested using the mdt-50. A leak was noted during the test. The unit failed leak test. Under microscopic inspection, abrasions were noted approximately 15. 5cm from the distal tip of the catheter. See other remarks section. Other remarks: 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 blood in the helium pathway is confirmed. The bladder had a full thickness abrasion which allowed blood to enter the iab. The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.
 
Event Description
It was been reported via a hotline call to the clinical support specialist (css). The registered nurse (rn) in the cardiovascular recovery is calling to report possible helium loss alarm and specks of blood in the driveline. The first alarm was noted approx. 20 min prior to the css calling the rn back. The patient is 62 inches with a 30cc iab. The rn confirmed there are specks of blood in the driveline. The css instructed the rn to clamp the gas tubing, disconnect from the pump and have the iab removed within 30 min and save for return. The pa/np is at the bedside to pull the iab currently and they are not planning to insert another. According to the rn they will support the patient with vasoactive drips. No further questions for the css at this time. Length of iabp therapy prior to event: 13 hours.
 
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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 Key5913944
MDR Text Key53502739
Report Number1219856-2016-00191
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 08/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberIAB-06830-U
Device Lot Number18F15G0007
Other Device ID Number00801902003751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2015
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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