• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOOON PRODUCTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-06840-U
Device Problems Fluid Leak (1250); Gas Leak (2946)
Patient Problems Cardiomyopathy (1764); Heart Failure (2206)
Event Date 08/04/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the event involved 163 cm in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).
 
Manufacturer Narrative
(b)(4). Evaluation: the bladder thickness was measured at six points and was within specification. The one-way valve was tested and passed all tests. A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip with minimal resistance met approximately 73. 5cm from the distal tip of the iab. The guidewire was front loaded through the iab luer with no resistance met. Blood exited with the guidewire. The iab was submerged in water and leak tested. Bubbles exited immediately from the bladder. There was a hole in an abraded area approximately 22. 7cm from the distal tip of the iab. The abrasion is approximately 8mm wide. The hole within the abrasion was < 1mm wide. No other holes or leaks were detected. Under microscopic investigation, a full thickness abrasion was confirmed at the leak site location. The abrasion is consistent with repeated contact with calcified plaque. See other remarks section. Other remarks: the ifu's state "intra-aortic balloon membrane perforation may occur during iabp therapy. The occurrence and severity of iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation. If balloon perforation is suspected, remove iab immediately using recommended removal technique". Perforation can cause blood to appear in the balloon catheter and driveline tubing. 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 helium pathway is confirmed. The iab bladder has 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. The root cause is associated with the presence of atherosclerotic plaques which can damage the balloon membrane.
 
Event Description
It was reported that the event involved (b)(6) in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).
 
Manufacturer Narrative
(b)(4). Visual investigation: the serial number of the sample is (b)(4). The sample was returned in a return kit box and sealed biohazardous bag. Returned for evaluation was a 40cc 7. 5fr ultraflex iab without the original packaging. Traces of blood were noted on the all exterior surfaces of the iab and 1-way valve. Dried blood was noted on the interior surfaces of the bladder and in the short driveline tubing. The cathgard was on the catheter approximately 64. 5cm from the distal tip of the bladder. Iab hemostasis cuff was connected to the cathgard. There was a slight bend on the catheter located approximately 73. 5cm from the distal tip of the iab. There was a small piece of a suture attached to the wing of the bifurcation cuff. The one-way valve was connected to the short driveline tubing. The bladder was fully unwrapped.
 
Event Description
It was reported that the event involved (b)(6) in height. While in the cath lab the intra-aortic balloon (iab) was prepped and the md inserted the iab sheathless via the patient's axillary site. The patient was moved to the cardiovascular intensive care unit (cvicu). At a time not noted; the pump (non-arrow) provided gas loss alarms, and the pump was changed out. The second pump went two hours without gas loss alarms, then began having alarms. Specks of blood backed up into the tubing. The patient required medical / surgical intervention to remove the iab and insertion another iab in the same insertion site. There was a delay in iabp therapy or 25 minutes. Pump strips were generated but are not available for review. X-rays were not performed. There was no reported patient death, injury or complications. The length of time prior to the event is 5 hours. The patient outcome is listed as patient had catheter replaced and is back on pump (iabp therapy).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAFLEX IAB: 7.5FR 40CC
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 Key5913819
MDR Text Key53477091
Report Number1219856-2016-00185
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,Followup
Report Date 08/05/2016
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? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberIAB-06840-U
Device Lot Number18S16C0001
Other Device ID Number00801902026804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2016
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 Manufactured03/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-