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

Catalog Number IAB-05840-LWS

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) ruptured while in use.The intra-aortic balloon pump (iabp) alarmed for high pressure.As a result, a new iab was used to complete the treatment.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).The reported complaint of blood in helium pathway is confirmed.A puncture to the bladder membrane, consistent with contact from a sharp object, was confirmed and allowed blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined, but a potential cause of how the catheter came into contact with a sharp object is customer handling.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.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured while in use.The intra-aortic balloon pump (iabp) alarmed for high pressure.As a result, a new iab was used to complete the treatment.There was a report of delay in therapy.There was no report of patient complications, serious injury or death.

• 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: 9193507
• MDR Text Key: 183316225
• Report Number: 3010532612-2019-00371
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17L0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.