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U.S. Department of Health and Human Services

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

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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 Cardiogenic Shock (2262); Blood Loss (2597)
Event Date 08/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). See 1219856-2016-00184 for first reported involving the same patient. The sample was returned with the supplied return kit. The one-way valve was connected and tethered to the short driveline tubing. Blood was observed on the exterior of the bifurcate, cathgard, bladder and on the interior of the bladder and short driveline tubing. Blood was noted on the exterior of the one-way valve. The bladder membrane was fully unwrapped. A bend was noted at approximately 6. 0cm from the iab distal tip. The catheter was bent/kinked and the central lumen appeared kinked/broken approximately 72. 6cm from the iab distal tip. The bladder thickness was measured at six points with measurements within specification of process document. 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. See other remarks section. Other remarks: the iab was submerged in water and leak tested using the mdt-50. Air was immediately being released from the iab distal tip and luer. A leak was also noticed from the bladder membrane. Under microscopic investigation the central lumen was confirmed broken at approximately 73. 0cm from the iab distal tip. The iab was re-submerged in water, with the iab luer and distal tip blocked off, and leak tested using the mdt-50. A leak/puncture was noted starting at approximately 24. 8cm to 25. 8cm from the iab distal tip. Under microscopic investigation, two puncture's to the bladder membrane are confirmed and the appearance is consistent with contact with a sharp. The length of each puncture is approximately 1. 0cm. No other leaks were noted. An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to the broken central lumen. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. Resistance was noted at approximately 6. 0cm from the iab distal tip. The guidewire could not advance at approximately 73. 2cm. Blood was noted on the guidewire upon removal. The guidewire was front loaded through the iab luer. Resistance was noted at approximately 9. 2cm from the iab the iab luer. The guidewire exited the broken central lumen and entered the outer lumen beyond this point. 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 was found kinked, and the central lumen was broken at this location. The broken central lumen likely allowed blood to enter the helium pathway. Upon leak testing, the bladder was found with a puncture consistent of contact with a sharp object. The bladder puncture likely occurred after removal. The root cause of the broken central lumen is undetermined.
 
Event Description
It was reported that the second iab was prepped and inserted into the same site as the removed iab. It too was inserted sheathless via the patient's axillary site. After three days of receiving iabp therapy blood was noted in the helium line. The pump (non-arrow) did not alarm. The iab was removed and another iab was inserting into the same insertion site. There was a 25 minute delay in iabp therapy. The patient is back on iabp therapy awaiting heart transplant. There was no reported death or injuries.
 
Manufacturer Narrative
(b)(4). See 1219856-2016-00184 for first reported involving the same patient. The sample was returned with the supplied return kit. The one-way valve was connected and tethered to the short driveline tubing. Blood was observed on the exterior of the bifurcate, cathgard, bladder and on the interior of the bladder and short driveline tubing. Blood was noted on the exterior of the one-way valve. The bladder membrane was fully unwrapped. A bend was noted at approximately 6. 0cm from the iab distal tip. The catheter was bent/kinked and the central lumen appeared kinked/broken approximately 72. 6cm from the iab distal tip. The bladder thickness was measured at six points with measurements within specification of process document. 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. Air was immediately being released from the iab distal tip and luer. A leak was also noticed from the bladder membrane. Under microscopic investigation the central lumen was confirmed broken at approximately 73. 0cm from the iab distal tip. The iab was re-submerged in water, with the iab luer and distal tip blocked off, and leak tested using the mdt-50. A leak/puncture was noted starting at approximately 24. 8cm to 25. 8cm from the iab distal tip. Under microscopic investigation, two puncture's to the bladder membrane are confirmed and the appearance is consistent with contact with a sharp. The length of each puncture is approximately 1. 0cm. No other leaks were noted. An attempt to aspirate and flush the catheter using a 60cc lab-inventory syringe was unable to be successfully completed due to the broken central lumen. A lab inventory 0. 025in guidewire was back loaded through the iab distal tip. Resistance was noted at approximately 6. 0cm from the iab distal tip. The guidewire could not advance at approximately 73. 2cm. Blood was noted on the guidewire upon removal. The guidewire was front loaded through the iab luer. Resistance was noted at approximately 9. 2cm from the iab the iab luer. The guidewire exited the broken central lumen and entered the outer lumen beyond this point. 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 was found kinked, and the central lumen was broken at this location. The broken central lumen likely allowed blood to enter the helium pathway. Upon leak testing, the bladder was found with a puncture consistent of contact with a sharp object. The bladder puncture likely occurred after removal. The root cause of the broken central lumen is undetermined.
 
Event Description
It was reported that the second iab was prepped and inserted into the same site as the removed iab. It too was inserted sheathless via the patient's axillary site. After three days of receiving iabp therapy blood was noted in the helium line. The pump (non-arrow) did not alarm. The iab was removed and another iab was inserting into the same insertion site. There was a 25 minute delay in iabp therapy. The patient is back on iabp therapy awaiting heart transplant. There was no reported death or injuries.
 
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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 Key5904578
MDR Text Key53043517
Report Number1219856-2016-00188
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 Received08/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Catalogue NumberIAB-06840-U
Device Lot Number18F16A0047
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 Received08/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2016
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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