• 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. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS

  • 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. REDIGUARD IAB: 8FR 40CC INTRA- AORTIC BALLOOON PRODUCTS Back to Search Results
Catalog Number IAB-S840C
Device Problems Occlusion Within Device (1423); Aspiration Issue (2883)
Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)
Event Date 04/14/2016
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: (b)(4).
 
Event Description
It was reported that the event occurred in the cath lab. The medical doctor found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless. The iab was placed in the "arcus aorta". The medical doctor could not aspirate the central lumen and the md decided to remove the iab. According to the report the md found it difficult to insert the wire into the central lumen. There was no reported patient death or injury. There was a reported complication of being hemodynamically not stable. The intervention required was a ptca (percutaneous transluminal coronary angioplasty). The patient received a competitor's iab via the same insertion site successfully.
 
Manufacturer Narrative
Concomitant medical products: (b)(4). This mdr was submitted in error and is a duplicate of 1219856-2016-00113 initially submitted on (b)(6) 2016.
 
Event Description
It was reported that the event occurred in the cath lab. The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless. The iab was placed in the "arcus aorta". The md could not aspirate the central lumen and the md decided to remove the iab. According to the report the md found it difficult to insert the wire into the central lumen. There was no reported patient death or injury. There was a reported complication of being hemodynamically not stable. The intervention required was a ptca (percutaneous transluminal coronary angioplasty). The patient received a competitor's iab via the same insertion site successfully.
 
Manufacturer Narrative
Concomitant medical products: (b)(4). No product was returned for evaluation. A device history record (dhr) review was unable to be completed. No lot number was reported. The lot numbers at this account are unable to be retrieved at this time. When the dhr is completed, the complaint will be updated accordingly. The reported complaint of unable to aspirate/flush is not able to be confirmed. No product was returned for evaluation. The root cause of the complaint is undetermined. If the sample is returned at a later date, a full investigation will be completed.
 
Event Description
It was reported that the event occurred in the cath lab. The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless. The iab was placed in the "arcus aorta". The md could not aspirate the central lumen and the md decided to remove the iab. According to the report the md found it difficult to insert the wire into the central lumen. There was no reported patient death or injury. There was a reported complication of being hemodynamically not stable. The intervention required was a ptca (percutaneous transluminal coronary angioplasty). The patient received a competitor's iab via the same insertion site successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREDIGUARD IAB: 8FR 40CC
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 Key6074696
MDR Text Key59055983
Report Number1219856-2016-00260
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAB-S840C
Device Lot NumberN/A
Other Device ID Number00801902002679
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
Treatment
PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLAS
-
-