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

Catalog Number IAB-06840-U

Device Problem Inflation Problem (1310)

Patient Problem Congestive Heart Failure (1783)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

It was reported that while in the cath lab the m.D.Inserted the intra-aortic balloon (iab) via a sheath into the patient's right femoral artery.Immediately the staff reported that under fluoroscopy they saw that the iab only partially unwrapped and it appeared the distal portion was not unwrapping.As a result, they did a manual inflation of the balloon, however inflation was met with resistance.The pump (iap-0500, s/n (b)(4)) did alarm, but the staff is unsure if it was high pressure or helium loss.The iab was removed and replaced using the same insertion site.There was a reported delay / interruption in iabp therapy of five minutes.There were no reported patient complications, injury or patient death.Medical/surgical intervention was not required.Pump strips were not generated and x-rays are not available for review.The patient is currently in ccu (cardiac care unit).

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 rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4511130
• MDR Text Key: 5494867
• Report Number: 1219856-2015-00027
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• 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 Age: 59 YR
• Patient Weight: 157