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

Catalog Number IAB-05840-LWS

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation; therefore, the reported complaint that the "balloon was not intact" 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: re: medwatch report # (b)(4).Teleflex received an mdr from fda (ref: (b)(4)) on 2/20/2019.At the time of receipt, we reviewed the information and conducted a search of our complaint tracking system that showed a match of a similar complaint that was already received, including the same account information with similar event details, which also occurred on the same month date.At that time we linked and attached the mdr from fda to the existing complaint in our system, ref: teleflex # (b)(4).During further evaluation of the complaint details, we recognized the complaint did not correctly match the information reported on the mdr from fda.Once we realized the error, we removed the mdr reference from the complaint (ref: teleflex # (b)(4)) and immediately opened a new complaint to link the mdr to a new complaint (ref: teleflex # (b)(4)).For this reason, we are submitting the initial mdr late.This is considered to be an isolated incident due to human error.(b)(4), post market surveillance manager contacted fda (1-888-info-fda (1-888-463-6332) to explain the situation that occurred.The fda stated that the error should be explained on the late mdr submitted and within the complaint file.

Event Description

It was reported that the event occurred during a cardiac catherization.When the intra-aortic balloon (iab) was removed, it was noted by the staff that the balloon was not intact.The patient received a coronary stent and the procedure was very successful.There was no report of patient death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 8565678
• MDR Text Key: 144155928
• Report Number: 3010532612-2019-00139
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17C0006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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