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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA-AORTIC BALLOON
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ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA-AORTIC BALLOON Back to Search Results
Catalog Number IAB-S840C
Device Problem Aspiration Issue (2883)
Patient Problems Hemorrhage/Bleeding (1888); Cardiogenic Shock (2262)
Event Date 04/14/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the doctor in the cath lab that the intra-aortic balloon (iab) was inserted in the right femoral artery and they could not do aspiration.They had difficulty with spring wire guide entry into the balloon to remove the balloon.They inserted introducer sheath 8fr and replaced the balloon with an ultra 35cc/ 7fr; they had no problem aspirating.There was no reported patient death.There was a delay /interruption in therapy and complication of hemorrhage, not stable.
 
Manufacturer Narrative
(b)(4).No product has been returned for evaluation.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product has been returned for evaluation.If the product is returned at a later date, a full investigation will be take place.The root cause of the complaint is undetermined.
 
Event Description
It was reported by the doctor in the cath lab that the intra-aortic balloon (iab) was inserted in the right femoral artery and they could not do aspiration.They had difficulty with spring wire guide entry into the balloon to remove the balloon.They inserted introducer sheath 8fr and replaced the balloon with an ultra 35cc/ 7fr; they had no problem aspirating.There was no reported patient death.There was a delay /interruption in therapy and complication of hemorrhage, not stable.
 
Manufacturer Narrative
(b)(4).No product has been returned for evaluation.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product has been returned for evaluation.If the product is returned at a later date, a full investigation will be take place.The root cause of the complaint is undetermined.Other remarks: teleflex received the device for analysis.The reported complaint of "could not do aspiration" of central lumen is not confirmed; however, the device had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the bends 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 will continue to monitor for any developing trends.
 
Event Description
It was reported by the doctor in the cath lab that the intra-aortic balloon (iab) was inserted in the right femoral artery and they could not do aspiration.They had difficulty with spring wire guide entry into the balloon to remove the balloon.They inserted introducer sheath 8fr and replaced the balloon with an ultra 35cc/ 7fr; they had no problem aspirating.There was no reported patient death.There was a delay /interruption in therapy and complication of hemorrhage, not stable.
 
Manufacturer Narrative
(b)(4).No product has been returned for evaluation.Conclusion: the reported complaint of central lumen occluded is not able to be confirmed.No product has been returned for evaluation.If the product is returned at a later date, a full investigation will be take place.The root cause of the complaint is undetermined.Other remarks: teleflex received the device for analysis.The reported complaint of "could not do aspiration" of central lumen is not confirmed; however, the device had numerous bends to the central lumen which may have caused the reported complaint.The root cause of the bends 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 will continue to monitor for any developing trends.It is important to note that this complaint was reported on april 14, 2016 and no device was returned.At that time teleflex conducted a dhr review and an investigation of the information we received and closed the complaint after we submitted a follow up mdr #1.Then on march 28, 2017 the device was returned for an evaluation.It was stated that the device was held up in customs, contributing to the extensive delay.We completed an investigation of the returned device and submitted a follow up mdr #2.On april 6, 2017 we received additional information that the reported event was not a complication of hemorrhage but instead a hemodynamic unstable condition.Therefore, this follow up #3 is being submitted only to clarify the new information we received regarding the event details.
 
Event Description
It was reported by the doctor in the cath lab that the intra-aortic balloon (iab) was inserted in the right femoral artery and they could not do aspiration.They had difficulty with spring wire guide entry into the balloon to remove the balloon.They inserted introducer sheath 8fr and replaced the balloon with an ultra 35cc/ 7fr; they had no problem aspirating.There was no reported patient death.There was a delay /interruption in therapy and complication of hemorrhage, not stable.
 
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Brand Name
REDIGUARD IAB: 8FR 40CC
Type of Device
INTRA-AORTIC BALLOON
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key5672951
MDR Text Key45694941
Report Number1219856-2016-00113
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeID
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 05/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue NumberIAB-S840C
Device Lot Number18F15G0018
Other Device ID Number00801902002679
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/03/2016
Initial Date FDA Received05/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received06/24/2016
03/30/2017
05/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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