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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC INTRA-AORTIC BALLOON

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC INTRA-AORTIC BALLOON Back to Search Results
Catalog Number IAB-S730C
Device Problem Aspiration Issue (2883)
Patient Problem Angina (1710)
Event Date 02/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that intra-aortic balloon pump (iabp) therapy was to be used for cardiac support. While in the intensive care unit and during insertion of the intra-aortic balloon (iab) via a sheath in the patient's right femoral artery, the clinician tried to aspirate blood from the central lumen of the catheter but failed. The iab was removed and another iab was not inserted. The patient was kept under close observation. There was a reported delay / interruption in iabp therapy however the timeframe is not available. There was no reported patient death, injury or complications. Medical / surgical intervention was not required. The patient outcome is stable.
 
Manufacturer Narrative
(b)(4). Additional information stated that the iab was prepped per the instructions for use prior to insertion. It is unknown if the patient had torturous vessels. The md reported that the patient was transferred to the cath lab for further treatment. Device evaluation: returned for evaluation was a 30cc 7. 0fr iab. The one-way valve was connected to the inflation lumen. The catheter was returned with approximately half the bladder membrane withdrawn within the saf sheath. The proximal end of the sheath was located approximately 73. 5cm from the luer end of the catheter. The catheter was returned with a spring wire guide (swg) fully inserted through the central lumen. Some dried blood was noted at the tip of the sheath. After removing the sheath from the catheter, dried blood was noted on the bladder membrane of the catheter. 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. No holes or leaks were detected. Full inflation was achieved. The unit passed leak test. See other remarks section for continuation. Other remarks: the swg returned with the catheter was removed from the device. A kink was found on the swg approximately 70. 0cm from the distal end. Some dried blood was noted on the swg after removal. The swg was able to be aspirated and flushed with air. A lab inventory swg was front loaded through the luer end of the iab. Some resistance was encountered approximately 16. 0cm from the luer end. The swg was able to advance; no blood or debris exited with the swg. The swg was back loaded through the iab distal tip. Some resistance was noted approximately 70. 0cm from the distal tip of the catheter. The swg was able to advance; no blood exited with the swg. A small set of grooves were felt along the outer lumen approximately 70. 0cm from the distal tip at the area of the previously noted resistance. A kink was noted beneath the outer lumen on the central lumen at this location. The kink was likely the cause of the resistance felt with the swg. A device history record 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 that the central lumen was occluded is confirmed. A kink on the central lumen was found and some dried blood was noted on the returned swg upon removal. The root cause of the kink is undetermined.
 
Event Description
It was reported that intra-aortic balloon pump (iabp) therapy was to be used for cardiac support. While in the intensive care unit and during insertion of the intra-aortic balloon (iab) via a sheath in the patient's right femoral artery, the clinician tried to aspirate blood from the central lumen of the catheter but failed. The iab was removed and another iab was not inserted. The patient was kept under close observation. There was a reported delay / interruption in iabp therapy however the timeframe is not available. There was no reported patient death, injury or complications. Medical / surgical intervention was not required. The patient outcome is stable.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceINTRA-AORTIC BALLOON
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5467247
MDR Text Key39257194
Report Number1219856-2016-00049
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2016
Device Catalogue NumberIAB-S730C
Device Lot Number18F14C0003
Other Device ID Number00801902002686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2014
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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