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

Model Number IPN000262

Device Problems Fluid/Blood Leak (1250); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on a patient, there was difficulty implanting the intra-aortic balloon (iab).There was a small resistance at the beginning of insertion, and there was blood found leaking along the balloon, and then the resistance increased more and more, which was difficult to insert.After multiple failed attempts the operation was terminated per superior doctor.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab insertion difficulty is not able to be confirmed.Upon return, the iab was fully inserted within a supplied super arrow-flex sheath with no resistance or damage noted.The balloon membrane was fully intact with no abnormalities noted.The returned device passed visual and functional test specifications.The root cause of the complaint is undetermined.No further action required at this time.

Event Description

It was reported that during use on a patient, there was difficulty implanting the intra-aortic balloon (iab).There was a small resistance at the beginning of insertion, and there was blood found leaking along the balloon, and then the resistance increased more and more, which was difficult to insert.After multiple failed attempts the operation was terminated per superior doctor.There was no report of patient complications, serious injury or death.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9512857
• MDR Text Key: 184672406
• Report Number: 3010532612-2019-00452
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002686
• UDI-Public: 00801902002686
• Combination Product (y/n): N
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: IPN000262
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F18E0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 45