MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; INTRA- AORTIC BALLOON

Catalog Number IAB-06840-U

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Failure (2484)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: medwatch report #: mw5070552.

Event Description

It was reported via a user facility report (medwatch report) that a patient of 179cm in height had an intra-aortic balloon (iab) placed via the right femoral artery.The iab was placed after the patient had a cardiac arrest.The iab ruptured and it was decided not to replace the iab.Additional information received on 7/17/2017: it was reported that the patient expired on (b)(6) 2017 the patient no longer had the device.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of blood in the helium pathway is not able to be confirmed.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.Other remarks: medwatch report #: mw5070552.

Event Description

It was reported via a user facility report (medwatch report) that a patient of (b)(6)cm in height had an intra-aortic balloon (iab) placed via the right femoral artery.The iab was placed after the patient had a cardiac arrest.The iab ruptured and it was decided not to replace the iab.Additional information received on 7/17/2017: it was reported that the patient expired on (b)(6) 2017 the patient no longer had the device.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: INTRA- AORTIC BALLOON
• 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: 6723587
• MDR Text Key: 80442762
• Report Number: 1219856-2017-00156
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17B0021
• Other Device ID Number: 00801902026804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• 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: 69 YR