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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000262
Device Problem Failure to Advance (2524)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).Other remarks: see mdr# 3010532612-2020-00333 (b)(4) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted through oxford 8fr sheath, and was unsuccessful, then through 7fr sheath which was also unsuccessful.The balloon was noted to be damaged during removal.As a result, a new iab was used.There was no report of patient complications.
 
Manufacturer Narrative
Qn# (b)(4).No part has been returned to teleflex chelmsford for investigation.The reported complaint of catheter stuck in sheath is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.Additionally, it was noted from the complaint report that the user attempted to use different sheaths other than the sheaths supplied in the iabc kit, which can indicate that the user did not follow the instructions for use (ifu) and the iabc may get stuck in sheath or other damage.As a result, an in-service for the customer has been requested to reiterate the ifu and the importance of the sheath selection.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00333 (tc 1900080345) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted through oxford 8fr sheath and was unsuccessful, then through 7fr sheath which was also unsuccessful.The balloon was noted to be damaged during removal.As a result, a new iab was used.There was no report of patient complications.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab catheter stuck in sheath is not able to be confirmed.During the investigation, the returned intra-aortic balloon catheter (iabc) was noted damaged, and this damage noted to the iabc outer lumen and teflon sheath extrusion is consistent with being cut.No blood was noted within the helium pathway.The damage to the iabc and sheath potentially occurred after the removal of the iabc from the patient.The cause of the reported complaint could not be determined.An in-service has been requested to review the instructions for use (ifu) with the customer, including the appropriate method for iabc prep/removal from its packaging and the importance of the sheath selection.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2020-00333 (b)(6) as the report is related to the same patient.
 
Event Description
It was reported that the intra-aortic balloon (iab) was inserted through oxford 8fr sheath and was unsuccessful, then through 7fr sheath which was also unsuccessful.The balloon was noted to be damaged during removal.As a result, a new iab was used.There was no report of patient complications.
 
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Brand Name
REDIGUARD IAB: 7FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
kaylia pen
16 elizabeth drive
chelmsford, MA 01824
MDR Report Key10830058
MDR Text Key216332849
Report Number3010532612-2020-00334
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902002686
UDI-Public00801902002686
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Model NumberIPN000262
Device Catalogue NumberIAB-S730C
Device Lot Number18F20A0008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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