MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 7.5 FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06840-U

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

It was reported that the event involved a pt while in the cardiac care unit during use.On (b)(6) 2014 while in the cath lab the md inserted the iab-06840-u through the sheath via femoral artery without issue.On (b)(6) 2014 the md attempted to remove the intra-aortic balloon (iab) at bedside and encountered difficulty during the removal; resistance was met.X-ray guidance was arranged.The spring wire guide (swg) was inserted inside the iab and then the iab was removed.It was stated the md is a senior and very experienced with arrow catheters.There was no report of pt death, complications, injury or medical/surgical intervention required.There was no delay or interruption in therapy since this event occurred during removal of the iab.The pt outcome is stable.Additional info received stated that the iab was able to be aspirated 3 times via 50 ml syringe.It was confirmed that they were able to remove the sheath and iab together as one unit completely/successfully without surgical/medical intervention after the second trial with a swg inserted.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 7.5 FR - 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: 4073825
• MDR Text Key: 4900253
• Report Number: 1219856-2014-00115
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K000729
• 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: 06/05/2014

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 Expiration Date: 12/31/2015
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F13M0019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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 Age: 57 YR
• Patient Weight: 68