MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 8 FR - 40 CC FOS; INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS)

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem Valvular Stenosis (2697)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It was reported that the event occurred during use while in the cardiac surgery dept.Indication for use: coronary artery bypass graft surgery.The iab-05840-lws was inserted via left femoral artery without issue 12 hrs prior to this event.The intra-aortic balloon pump (iabp) alarmed "high pressure" and large helium leak detected; blood was observed inside the tubing.As a result, the md decided to remove and replace the iab immediately.The md attempted to remove the intra-aortic balloon (iab) and met strong resistance during withdrawal.After the iab was removed, blood was found inside.A new iab was inserted via right femoral artery without issue and iabp therapy proceeded as planned.There was no report of pt death, complications or injury.No medical/surgical intervention was required.There was an unk time of delay or interruption in therapy with no harm to the pt noted.The pt outcome was fine.Updated info received stated that the fiberoptix sensor (fos) did work appropriately during product prep and after insertion.After the pump alerted and blood was observed in the line, the iab was removed right away within the 30 minutes as recommended successfully.They were able to remove the iab completely without surgical intervention.The delay in therapy was approximately 50 minutes with no harm to the pt.They were able to successfully finish iabp therapy as planned with the second iab inserted without issue via right femoral artery.The doctor did not use a sheath during insertion.There are no pump strips available for review.The pump worked appropriately (autocat2wave, serial number (b)(4)).The pt outcome is fine after iabp therapy.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS)
• 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 associa ; 2400 benrville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3919030
• MDR Text Key: 4518276
• Report Number: 1219856-2014-00110
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2014

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-05840-LWS
• Device Lot Number: KF3014952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• 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): Other
• Patient Age: 61 YR
• Patient Weight: 77