MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000302

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).See mdr# 3010532612-2020-00005 and tc (b)(4) as the report is related to the same patient.

Event Description

It was reported the intra-aortic balloon pump (iabp) was in use on a patient.The engineer stated that the blood clot was sighted 10 hours prior to stopping the pump.It was noted that the iabp did not register a leak.As a result, the iab was removed without incidence.There was no report of patient complications, serious injury or death.

Event Description

It was reported the intra-aortic balloon pump (iabp) was in use on a patient.The engineer stated that the blood clot was sighted 10 hours prior to stopping the pump.It was noted that the iabp did not register a leak.As a result, the iab was removed without incidence.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of iabp did not alarm during balloon rupture is not able to be confirmed.In the photos provided, blood was noted in the helium pathway of the iab catheter, and according to the details of the event, the pump did not alarm.However, the pump was inspected by the hospital's trained biomed and confirmed the alarm system was working to specification.The root cause of this 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: see mdr# 3010532612-2020-00005 and tc1900074575 as the report is related to the same patient.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9601449
• MDR Text Key: 188346495
• Report Number: 3010532612-2020-00006
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000302
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1