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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the event involved a patient in the operating theatre prior to surgical procedure. The iab was inserted via the patient's right femoral artery. The iabp therapy / pump had been functioning without issue. Per the cnc, "about 30 hours post iab insertion there was a "helium loss alarm", there had been no patient movement or anything preceding the helium loss alarm. The pump was reset and blood noted to appear in catheter. " as a result, the counterpulsation was stopped and catheter was removed. The iab was not replaced. There were no reported patient complications, or patient injuries. There was medical / surgical intervention required and described as "iabp stopped and catheter removed. ".
 
Manufacturer Narrative
(b)(4) additional information received, the patient did not have the iab surgically removed. Following removal of catheter the patient remained stable with no significant increase in pharmacological support. The patient did have multiple ectopic foci thought to be a result of the reduced cardiac perfusion but this did not require any intervention. Blood did not back up into the pump. Evaluation: returned for evaluation was a 30cc 7. 5fr ultraflex. The distal end of the teflon sheath was approximately 24. 2cm from the iab distal tip. The teflon sheath was connected to the iab hemostasis cuff which was connected to the cathgard. Blood was observed on the exterior of the sheath, bifurcate, bladder, outer lumen and on the interior of the bladder and short driveline tubing. The one-way valve was connected and tethered to the short driveline tubing. Dried blood was noted on the exterior of the one-way valve. The bladder was fully unwrapped. A bend was noted at approximately 67. 5cm from the iab distal tip. The bladder thickness was measured at six points with measurements within specification. See other remarks section. 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 was immediately noticeable from bladder membrane. Under microscopic inspection, abrasions were observed at approximately 19. 6cm from the iab distal tip. A full thickness abrasion to the bladder was confirmed and the appearance is consistent with repeated contact with calcified plaque on the aortic wall. The catheter was aspirated and flushed using a 60cc lab-inventory syringe. No abnormalities or debris were noted. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. Resistance was noted at approximately 67. 9cm 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 9. 3cm 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 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.
 
Event Description
It has been reported that the event involved a patient in the operating theatre prior to surgical procedure. The iab was inserted via the patient's right femoral artery. The iabp therapy / pump had been functioning without issue. Per the cnc, "about 30 hours post iab insertion there was a "helium loss alarm", there had been no patient movement or anything preceding the helium loss alarm. The pump was reset and blood noted to appear in catheter. " as a result, the counterpulsation was stopped and catheter was removed. The iab was not replaced. There were no reported patient complications, or patient injuries. There was medical / surgical intervention required and described as "iabp stopped and catheter removed. ".
 
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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 Key5792361
MDR Text Key49500041
Report Number1219856-2016-00158
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K000729
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 06/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2016
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 Number18S15A0019
Other Device ID Number00801902003751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2016
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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