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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000263
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).For related complaint on the same patient and event see mdr #3010532612-2019-00358 and (b)(4).
 
Event Description
It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
 
Event Description
It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc # (b)(4).
 
Manufacturer Narrative
Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of central lumen occluded is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: for related complaint on the same patient and event see mdr #3010532612-2019-00358 and tc #(b)(4).The complaint was reopened to investigate the device that was returned to teleflex.The reported complaint of central lumen occluded is not confirmed.During functional testing, no blockage or occlusion was noted.The returned device passed functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.No further action required at this time.
 
Event Description
It was reported that on the intra-aortic balloon (iab) after the spring wire guide (swg) was removed, there was no blood when withdrawing the syringe and the same issue occurred after trying many times.The doctor judge preliminary that the central lumen was blocked.As a result, the catheter was removed and another catheter was not inserted.There was no report of patient death.
 
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Brand Name
REDIGUARD IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9137285
MDR Text Key182374998
Report Number3010532612-2019-00347
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002679
UDI-Public00801902002679
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Model NumberIPN000263
Device Catalogue NumberIAB-S840C
Device Lot Number18F17E0012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Initial Date Manufacturer Received 09/09/2019
Initial Date FDA Received09/30/2019
Supplement Dates Manufacturer Received10/29/2019
03/05/2020
Supplement Dates FDA Received10/30/2019
03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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