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

Model Number IPN000320

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the problem occurred when the staff tried to hook up the helium tank to the intra-aortic balloon pump (iabp).It appeared the metal piece in the black component that the helium tank goes in was bent and therefore the tank would not hook up.As a result, the doctor used a new iabp and everything worked fine.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the problem occurred when the staff tried to hook up the helium tank to the intra-aortic balloon pump (iabp).It appeared the metal piece in the black component that the helium tank goes in was bent and therefore the tank would not hook up.As a result, the doctor used a new iabp and everything worked fine.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of difficulty connecting the helium tank 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 revived risk.This will be monitored for any developing trends.Other remarks: additional information received regarding the event.The linked complaint was generated and made reportable upon receiving further information.See mdr# 3010532612-2020-00161 (tc1900077241) 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: 10123466
• MDR Text Key: 194344993
• Report Number: 3010532612-2020-00153
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1