MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0400

Device Problems Device Alarm System (1012); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: for related complaint see mdr #1219856-2017-00314 and tc # (b)(4).

Event Description

It was reported that the event occurred on a patient of 173cm in height.The pump alarmed after 4 days use, helium leak.The volume was adjusted, the catheter was moved, the counter pulsation rate was adjusted, and the alarm can't be clear.As a result, the pump and the intra-aortic balloon (iab) were exchange.There were no reported patient deaths or complications to the patient.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "helium leak" is confirmed based on the returned iab finding.The iab was found with a leak.An external helium leak was confirmed from the iab bifurcate during functional testing.The pump functioned as intended.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.No further action required.Other remarks: for related complaint see mdr #1219856-2017-00314 and tc #1900056990.

Event Description

It was reported that the event occurred on a patient of 173cm in height.The pump alarmed after 4 days use, helium leak.The volume was adjusted, the catheter was moved, the counter pulsation rate was adjusted, and the alarm can't be clear.As a result, the pump and the intra-aortic balloon (iab) were exchange.There were no reported patient deaths or complications to the patient.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7139219
• MDR Text Key: 95812292
• Report Number: 1219856-2017-00338
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Other Device ID Number: 00801902051721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73