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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC INTRA- AORTIC BALLOOON PRODUCTS

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-R950-U
Device Problem Wrinkled (2614)
Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)
Event Date 09/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call from the registered nurse (rn) in the cardiac cath lab (ccl) regarding a sheath issue upon insertion. The sheath with the side arm "accordion" on itself, when the md attempted to insert the intra-aortic balloon catheter (iab) via the femoral artery. The registered nurse said the md was not using any force during insertion and everything was standard procedure. They were able to remove the sheath and replace it with the alternate sheath in the tray without difficulty. There was a delay with no patient complications. The patient was stable on the intra-aortic balloon pump and transferred from the ccl.
 
Manufacturer Narrative
(b)(4). Returned for evaluation was an 11. 5fr sheath and dilator from an iab-r950-u insertion kit. The dilator was fully inserted within the sheath. Damage to the sheath tip was noted. Buckling of the sheath was noted from approx. 9cm to 10cm from the dilator tip. The dilator tip and hub appeared typical. The sheath hub appeared typical. The sheath sidearm was fully connected. Some clear fluid was noted in the sheath sidearm. Spots of dried blood were noted the exterior of the device. The dilator was easily removed from the sheath. The sheath was inserted into the t-tube and pressurized to 200mmhg. The sheath and sidearm did not leak. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint of sheath damaged is confirmed. Upon visual inspection, damage to the sheath tip and buckling of the sheath body were noted. The damage to the sheath appears to be consistent with insertion difficulty. The root cause of the complaint is undetermined.
 
Event Description
It was reported via a hot line call from the registered nurse (rn) in the cardiac cath lab (ccl) regarding a sheath issue upon insertion. The sheath with the side arm "accordion" on itself, when the md attempted to insert the intra-aortic balloon catheter (iab) via the femoral artery. The rn said the md was not using any force during insertion and everything was standard procedure. They were able to remove the sheath and replace it with the alternate sheath in the tray without difficulty. There was a delay with no patient complications. The patient was stable on the intra-aortic balloon pump and transferred from the ccl.
 
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Brand NameREDIGUARD IAB: 9FR 50CC
Type of DeviceINTRA- AORTIC BALLOOON PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6026346
MDR Text Key57308209
Report Number1219856-2016-00225
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberIAB-R950-U
Device Lot Number18F16G0017
Other Device ID Number00801902010803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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