MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 8 FR - 30 CC FOS; INTRA-AORTIC BALLOON FIBEROPTIC SYST

Catalog Number IAB-05830-LWS

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2015

Event Type  Injury  

Event Description

It was reported that the event involved a male pt during removal of an iab-05830-lws while in the intensive care unit/surgery room.Approximately 24 hours prior to this event the doctor inserted the intra-aortic balloon (iab) through the sheath via left leg without issue and intra-aortic balloon pump (iabp) therapy was given as planned.While in the icu the doctor attempted to remove the iab and it was not possible because the iab was entrapped into the pt.As a result, the iab was surgically removed in the surgery room.There was not another iab inserted.There was no relay or interruption in the therapy noted.No report of pt death.The autocat2wave did not alarm and there were no pump strips generated or an x-ray for review since this was during removal.The pt outcome is good.Add'l info rec'd on 04feb2015 stated that iabp therapy was completed successfully as planned.They were able to completely remove all of the iab from the pt.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 8 FR - 30 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBEROPTIC SYST
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4510145
• MDR Text Key: 5411174
• Report Number: 1219856-2015-00025
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05830-LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention