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

Model Number IPN000254

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the staff initially called for help troubleshooting the ap waveform.The clinical support specialist (css) received another call at 1446 to troubleshoot cal key message on the intra-aortic balloon pump (iabp).During the conversation, a high-pressure alarm occurred, the staff stated there appear to be a kink at the groin and prior to restarting pumping, blood was noted in the gas line tubing.The staff disconnected the intra-aortic balloon (iab) from the pump and notify the md.The iab was immediately removed without incident or injury.Md chose not to reinsert, patient currently stable without iabp.Follow up call at 1700- patient remains stable off iabp.

Event Description

It was reported that the staff initially called for help troubleshooting the ap waveform.The clinical support specialist (css) received another call at 1446 to troubleshoot cal key message on the intra-aortic balloon pump (iabp).During the conversation, a high-pressure alarm occurred, the staff stated there appear to be a kink at the groin and prior to restarting pumping, blood was noted in the gas line tubing.The staff disconnected the intra-aortic balloon (iab) from the pump and notify the md.The iab was immediately removed without incident or injury.Md chose not to reinsert, patient currently stable without iabp.Follow up call at 1700- patient remains stable off iabp.

Manufacturer Narrative

(b)(4).The product was not returned 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.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

• 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: 12207307
• MDR Text Key: 262871138
• Report Number: 3010532612-2021-00224
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1