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

Model Number IPN039787

Device Problem Fluid/Blood Leak (1250)

Patient Problem Vascular Dissection (3160)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).See mdr# 3010532612-2020-00388 ((b)(4)) as the report is related to the same patient.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the staff noted small blood stains in the helium tube.The removal of the iab was attempted without success due to its incarceration in the left iliac-femoral axis.Contacted urgently the vascular surgery, the patient was transferred to an operative room to cut the artery and remove the device.The left inguinal incision allowed to appreciate the point of access of the iab at the origin of the superficial femoral.Despite a large transverse incision at the access, it was impossible to remove the balloon.An ultrasound study showed the presence of the iab balloon, proximally to the inferior mesenteric artery, incarcerated in the common iliac.No other iab was used.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the staff noted small blood stains in the helium tube.The removal of the iab was attempted without success due to its incarceration in the left iliac-femoral axis.Contacted urgently the vascular surgery, the patient was transferred to an operative room to cut the artery and remove the device.The left inguinal incision allowed to appreciate the point of access of the iab at the origin of the superficial femoral.Despite a large transverse incision at the access, it was impossible to remove the balloon.An ultrasound study showed the presence of the iab balloon, proximally to the inferior mesenteric artery, incarcerated in the common iliac.No other iab was used.

Manufacturer Narrative

(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of iab: blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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 revived risk.This will be monitored for any developing trends.Other remarks: corrected data: an error was made when referencing the teleflex complaint number.It was noted that the teleflex complaint number provided was incorrect.The correct verbiage is stated as follows: see mdr#: 3010532612-2020-00388 (b)(4) as the report is related to the same patient.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11056888
• MDR Text Key: 223175779
• Report Number: 3010532612-2020-00389
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: IPN039787
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20E0041
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.
• Patient Age: 78 YR