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

Catalog Number IAP-0500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event occurred during use on the patient.The field service report stated that the electrocardiogram (ecg) was not communicating with the pump.The balloon had missed beats with ventricular pace and pattern trigger.The cath lab requested the pump to be checked although it was believed to be from the patient's status.There was a report of patient death.It was confirmed by the biomedical engineer that the patient was in critical condition before being put on the pump and the pump had no involvement in patient death.The field service tech checked all ecg signal and leads.Both high and low level and pacer triggers.Both operator and auto and no trigger issues.The tech ran the pump for over 2 hours and no electrocardiogram or arterial pressure (ap) trigger problem occurred, pumped on pacer triggers.The tech also performed functional checks and all passed.The pump was return to service.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "cannot detect ecg signal" cannot be confirmed.The pump was checked by the field service engineer and no problem was found with the pump.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the event occurred during use on the patient.The field service report stated that the electrocardiogram (ecg) was not communicating with the pump.The balloon had missed beats with ventricular pace and pattern trigger.The cath lab requested the pump to be checked although it was believed to be from the patient's status.There was a report of patient death.It was confirmed by the biomedical engineer that the patient was in critical condition before being put on the pump and the pump had no involvement in patient death.The field service tech checked all ecg signal and leads.Both high and low level and pacer triggers.Both operator and auto and no trigger issues.The tech ran the pump for over 2 hours and no electrocardiogram or arterial pressure (ap) trigger problem occurred, pumped on pacer triggers.The tech also performed functional checks and all passed.The pump was return to service.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7345992
• MDR Text Key: 103009200
• Report Number: 3010532612-2018-00057
• Device Sequence Number: 1
• Product Code: DSP
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1