MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-S840C

Device Problems Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab.The md couldn't advance the intra-aortic balloon (iab) due to severe resistance even though the md stated following the instructions for use exactly.The md properly vacuumed the iab enough inside of the tray, but the iab was stuck in the sheath.As a result, the md removed the failed iab and sheath together successfully as one unit.It was replaced with a new kit and the procedure and iabp therapy went on a new kit and the procedure and iabp therapy went on as planned successfully.There was no report of patient death, complications or injury.No medical/surgical invention was required.There was no delay or interruption in therapy noted.There was no harmful outcome to the patient.Additional information received stated that the sheath used for the insertion was the super arrow-flex (saf) sheath.The second insertion was in the same site, right femoral artery.There was a reported 10 minute delay/interruption in iabp therapy.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4401943
• MDR Text Key: 5369410
• Report Number: 1219856-2014-00118
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S840C
• Device Lot Number: KF2094300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• 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