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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 11/29/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the event occurred during incoming inspection.When the iab kit arrived at the cath lab inventory from the warehouse, it was noted that the seal was broken, and the packaging was opened.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "the seal was broken and the packaging was open" 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.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint has been reopened to investigate the device that was returned to teleflex for investigation.The report complaint that "the seal was broken, and the packaging was opened" is not confirmed.The returned semi-finished kit packaging was fully sealed and met visual specifications during the investigation.The correct supplied components were returned for the original product.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 the event occurred during incoming inspection.When the iab kit arrived at the cath lab inventory from the warehouse, it was noted that the seal was broken, and the packaging was opened.There was no patient involvement.
 
Event Description
It was reported that the event occurred during incoming inspection.When the iab kit arrived at the cath lab inventory from the warehouse, it was noted that the seal was broken, and the packaging was opened.There was no patient involvement.
 
Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "the seal was broken and the packaging was open" 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.The reported complaint will be monitored for any developing trends.No further action required at this time.
 
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Brand Name
ULTRA 8 IAB: 8FR 30CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8184978
MDR Text Key131029986
Report Number3010532612-2018-00387
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902010742
UDI-Public00801902010742
Combination Product (y/n)N
PMA/PMN Number
K000729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Catalogue NumberIAB-06830-U
Device Lot Number18F18E0032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Date Manufacturer Received02/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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