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

Catalog Number IAB-S840C

Device Problems Failure to Advance (2524); Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab during insertion.The md stated having followed the procedure of the instructions for use.The md could not advance the iab-s840c through the sheath via femoral artery due to severe resistance.The md had properly vacuumed the intra-aortic balloon (iab) enough inside of the tray, but the iab was stuck in the sheath.As a result, the md removed the iab and sheath together as one unit and replaced it with a new kit via a different femoral artery site.Intra-aortic balloon pump (iabp) therapy went on successfully as planned with the second kit.The md stated there was no report of patient death, complications or injury.No medical/surgical intervention was required.There was an approximate 30 minute delay or interruption in therapy.The patient outcome is no harmful outcome to the patient.Additional information received on 04 september 2014 stated the patient did not have a tortuous vessel.They used the same insertion site with the second iab.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8FR - 40CC
• 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, ra ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4107384
• MDR Text Key: 18543141
• Report Number: 1219856-2014-00172
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2014

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: KF3055772
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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