MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000263

Device Problem Difficult to Advance (2920)

Patient Problem Death (1802)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during intra-aortic balloon pump (iabp) counterpulsation procedure it was noted that the intra-aortic balloon ( iab) could not pass through the sheath, so it was withdrawn.Subsequently, it was found that the patient's heart was arrested, and the cardiopulmonary resuscitation was unable to recover his heartbeat, and the patient died.The doctor zehan huang made the medical judgement that the device did not cause or contribute to the patient's death.

Event Description

It was reported that during intra-aortic balloon pump (iabp) counterpulsation procedure it was noted that the intra-aortic balloon ( iab) could not pass through the sheath, so it was withdrawn.Subsequently, it was found that the patient's heart was arrested, and the cardiopulmonary resuscitation was unable to recover his heartbeat, and the patient died.The doctor zehan huang made the medical judgement that the device did not cause or contribute to the patient's death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the "balloon could not pass through the sheath" is not able to be confirmed.The sheath in question was not returned for investigation.The returned intra-aortic balloon catheter (iabc) bladder membrane passed dimensional and functional inspection.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.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10634913
• MDR Text Key: 210017897
• Report Number: 3010532612-2020-00285
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902002679
• UDI-Public: 00801902002679
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F19K0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1