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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000254
Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the user found black dots inside the balloon when the intra-aortic balloon (iab) was removed from the patient.It was also noted that staff had to use fluoroscopy to remove the catheter.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed based on visual inspection of the device and the customer pictures provided with the complaint report.The cause of the complaint was unable to be determined due to the returned state of the device.The iab was returned with the ruptured bladder membrane.The appearance of the damaged bladder is consistent with being cut/ripped after the removal of the device from the patient.The root cause of how the blood entered the helium pathway 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.Additional information received that the patient was injured and developed thrombus and underwent precutaneous transluminal angioplasty (pta).
 
Event Description
It was reported that the user found black dots inside the balloon when the intra-aortic balloon (iab) was removed from the patient.It was also noted that staff had to use fluoroscopy to remove the catheter.There was no report of patient complications, serious injury or death.
 
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Brand Name
FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10206232
MDR Text Key198078264
Report Number3010532612-2020-00169
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902007247
UDI-Public00801902007247
Combination Product (y/n)N
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 06/11/2020
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? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F20B0011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Initial Date Manufacturer Received 06/11/2020
Initial Date FDA Received06/29/2020
Supplement Dates Manufacturer Received07/31/2020
Supplement Dates FDA Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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