MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8FR - 40 CC FOS; NONE

Catalog Number IAB-05840-LWS

Device Problems Bent (1059); Crack (1135); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2014

Event Type  Injury  

Event Description

It was reported that while in the cath lab the md inserted the intra-aortic balloon (iab) via the patient's left femoral artery.The distal tip of the catheter was "broken." a second iab was prepped and inserted into the same insertion site (left femoral).Additional information received from the rt states."we were inserting it and it went in smoothly no problems what so ever.Once it was in we tried to aspirate blood and got no blood return despite multiple efforts.We were using fluoro and didn't see anything abnormal.At that point we decided to pull it out and use another catheter because of the lack of blood return from the inner lumen of the balloon (sheath and balloon both pulled), once outside of the patient's body we noted that the metal liner lumen portion of the balloon catheter was cracked and actually bending as if it snapped.This is what caused no blood return.The catheter is still intact and this will be noted when you receive the balloon back.It cracked and bent, but did not rupture the actual balloon material or break off.Again it was all intact and nothing was dislodged into the patient.The outcome of the patient is ok; the only bad part of the faulty catheter was the patient had to undergo a second arterial stick and have a second sheath and balloon placed.Patient is currently still on the pump with catheter in place, and is stable.This procedure was done by a skilled physician so no deviations during insertion.".

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8FR - 40 CC FOS
• Type of Device: NONE
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn meyers, associate ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 3842786
• MDR Text Key: 15103645
• Report Number: 1219856-2014-00103
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2014

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: 01/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14A0067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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