• 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 Problem Fluid Leak (1250)
Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Blood Loss (2597)
Event Date 10/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call. There was no difficulty with insertion per the chief of perfusion in the operating room. An initial high pressure alarmed and the volume was reduced from 40cc to 38. 5cc no additional alarms until helium (he) loss alarms, moderate amount of blood noted in the tubing. The md removed the iab <15 minutes after blood noted. The iab was disconnected prior to blood reaching the pump. No difficulty with removal or complications noted post removal. An iab was not reinserted at this time, the patient was medically supported at last contact. Indication for iabp therapy: mi (previous cabg) length of time prior to event: a few minutes post insertion list specific iabp alarms that occurred: high pressure fb he loss alarms.
 
Manufacturer Narrative
(b)(4). The sample was returned in the supplied return kit and was in a sealed bio-hazard bag. The sample was tightly wrapped in bubble wrap. A bend on the iab was immediately noticed, which likely occurred in the return packaging. Upon return, the 40cc inflation driveline tubing was connected to the iab short driveline tubing. An ap pressure line was connected to the iab luer. The distal end of the teflon sheath was approximately 42. 3cm from the iab distal tip. The distal tip of the teflon sheath was noted slightly damaged. Liquid blood was noted in the sheath sidearm. The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard. Dried blood was noted on the exterior of the sheath, outer lumen, bifurcate and bladder. Dried blood was also noted on the interior of the bladder, outer lumen and driveline tubing. The bladder was fully unwrapped. The one-way valve was tethered to the short driveline tubing. A bend was noted at approximately 31cm from the iab distal tip. The bladder thickness was measured at six points with measurements within specification. Other remarks: 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. A leak/puncture was noted approximately 17. 6cm from the iab distal tip. Under microscopic investigation, a puncture to the bladder membrane is confirmed and the appearance is consistent with contact with a sharp. The catheter was aspirated and flushed using a 60cc lab-inventory syringe. Some blood/debris was noted. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. Resistance was noted at approximately 30. 5cm from the iab distal tip. The guidewire was able to advance through the central lumen. No blood or debris was noted. The guidewire was front loaded through the iab luer. Resistance was noted at approximately 51. 5cm from the iab luer. The guidewire was able to advance through the central lumen. No blood or debris was noted. 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 helium pathway is confirmed. The bladder membrane had a puncture consistent with contact from a sharp which allowed blood to enter the iab. The root cause of the puncture is undetermined.
 
Event Description
It was reported via a hot line call. There was no difficulty with insertion per the chief of perfusion in the operating room. An initial high pressure alarmed and the volume was reduced from 40cc to 38. 5cc no additional alarms until helium (he) loss alarms, moderate amount of blood noted in the tubing. The md removed the iab <15 minutes after blood noted. The iab was disconnected prior to blood reaching the pump. No difficulty with removal or complications noted post removal. An iab was not reinserted at this time, the patient was medically supported at last contact. Indication for iabp therapy: mi (previous cabg) length of time prior to event: a few minutes post insertion list specific iabp alarms that occurred: high pressure fb he loss alarms.
 
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 Key6131770
MDR Text Key61026729
Report Number1219856-2016-00243
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Catalogue NumberIAB-06840-U
Device Lot Number18F16F0032
Other Device ID Number00801902026804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2016
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: 11/29/2016 Patient Sequence Number: 1
Treatment
MEDICATION FOR SUPPORT.
-
-