MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC INTRA- AORTIC BALLOON FIBER OPTIC

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems Perforation of Vessels (2135); Injury (2348); Ischemic Heart Disease (2493)

Event Date 11/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted via a sheath into the patient's left femoral artery. After 36 hours of intra-aortic balloon pump (iabp) therapy blood was found in the helium tubing and the pump alarmed "stop assist". The md attempted to remove the balloon without success; the angiography attempt was impossible. As a result, the patient was taken to the cardio surgery department for vascular surgery. During the surgery the left common femoral artery was enlarged the iab was removed. The surgeon repaired the common femoral artery with a patch. According to the report, "after the iab was removed there was a visual examination and the catheter was found with a rupture of the balloon with a lot inside. " the patient did not receive a second iab and there was an interruption in iabp therapy. Pump strips were generated and are not available for review. X-rays were performed during the removal attempt. The x-ray findings are described as normal. The x-rays are available for review. There was no reported patient death. The patient outcome is listed as fine.

Manufacturer Narrative

Qn#(b)(4). Teleflex received the device for an analysis. The reported complaint of blood in the helium pathway is confirmed based on a visual inspection of the device. Blood was noted on the interior of the returned bladder membrane; however, the device could not be functionally tested due to the damaged state of the device upon return. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. No further action is required at this time. Teleflex will continue to monitor for similar reports.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted via a sheath into the patient's left femoral artery. After 36 hours of intra-aortic balloon pump (iabp) therapy blood was found in the helium tubing and the pump alarmed "stop assist". The md attempted to remove the balloon without success; the angiography attempt was impossible. As a result, the patient was taken to the cardio surgery department for vascular surgery. During the surgery the left common femoral artery was enlarged the iab was removed. The surgeon repaired the common femoral artery with a patch. According to the report, "after the iab was removed there was a visual examination and the catheter was found with a rupture of the balloon with a lot inside. " the patient did not receive a second iab and there was an interruption in iabp therapy. Pump strips were generated and are not available for review. X-rays were performed during the removal attempt. The x-ray findings are described as normal. The x-rays are available for review. There was no reported patient death. The patient outcome is listed as fine.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 3015 carrington mill blvd; morrisville, PA 27560 ; 6104783117
• MDR Report Key: 6194205
• Report Number: 1219856-2016-00293
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/31/2018
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F16C0052
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Outcome(s): Required Intervention