• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-06830-U
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that prior to insertion, the doctor removed the intra-aortic balloon (iab) catheter from the packaging and noted that a kink was on the catheter. The doctor attempted to insert the catheter through the already inserted sheath. It was noted that the kink did not allow the catheter to advance over the guidewire. As a result, the catheter was removed, and another balloon catheter was inserted with success. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iab kinked 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.
 
Event Description
It was reported that prior to insertion, the doctor removed the intra-aortic balloon (iab) catheter from the packaging and noted that a kink was on the catheter. The doctor attempted to insert the catheter through the already inserted sheath. It was noted that the kink did not allow the catheter to advance over the guidewire. As a result, the catheter was removed, and another balloon catheter was inserted with success. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of iab kinked 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 reported complaint of iab kinked is confirmed. Upon visual inspection, a bend was noted to the iab. Upon inserting a guidewire, resistance was experienced at the location of the bend. The bend on the iab can result in insertion difficulty. The root cause of the bend is undetermined but a potential cause is a result from the customer handling. 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. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that prior to insertion, the doctor removed the intra-aortic balloon (iab) catheter from the packaging and noted that a kink was on the catheter. The doctor attempted to insert the catheter through the already inserted sheath. It was noted that the kink did not allow the catheter to advance over the guidewire. As a result, the catheter was removed, and another balloon catheter was inserted with success. There was no report of patient complication or serious injury and death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAFLEX IAB: 7.5FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8196323
MDR Text Key131479459
Report Number3010532612-2018-00396
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902003751
UDI-Public00801902003751
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 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberIAB-06830-U
Device Lot Number18F18A0029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Is This a Reprocessed and Reused Single-Use Device? No

-
-