MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-05830-LWS

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Connection Problem (2900)

Patient Problem Hematoma (1884)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: bleeding after removal of the catheter and sheath.(b)(4).

Event Description

It was reported that prior to insertion the fiber optic sensor (fos) intra-aortic balloon (iab) catheter had an fos weak signal message.The registered nurse and the medical doctor disconnected and reconnected the fos and cal key with the same results.It was decided the catheter was problem.The md pulled the iab through the sheath and the tip got lodged inside the sheath.The iab was cut-down and then discarded.The iab was not replaced.Additional information received via a user facility report: the patient had bleeding at the site after loss of sheath placement and required a fem-stop and monitoring overnight in the intensive care unit.There was no reported death.

Manufacturer Narrative

Bleeding after removal of the catheter and sheath.(b)(4).Teleflex did not receive the device for investigation, therefore, the reported complaint of removal difficulty is unable to be confirmed.It was stated in the complaint report that catheter removal through the sheath was attempted.The teleflex instructions for use states "do not remove arrow iab through hemostasis sheath introducer or hemostasis device.Once unwrapped (unfurled), balloon profile will not allow passage through the sheath and attempted removal in this manner may result in arterial tearing, dissection or balloon damage." teleflex conducted an in-service at the hospital to address this.Other remarks: a device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.User facility report #: (b)(4).

Event Description

It was reported that prior to insertion the fiber optic sensor (fos) intra-aortic balloon (iab) catheter had an fos weak signal message.The rn and the md disconnected and reconnected the fos and cal key with the same results.It was decided the catheter was problem.The md pulled the iab through the sheath and the tip got lodged inside the sheath.The iab was cut-down and then discarded.The iab was not replaced.Additional information received via a user facility report: the patient had bleeding at the site after loss of sheath placement and required a fem-stop and monitoring overnight in the intensive care unit.There was no reported death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6897859
• MDR Text Key: 87612666
• Report Number: 1219856-2017-00217
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18S16K0035
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 54 YR
• Patient Weight: 75