MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000260

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the balloon of the intra-aortic balloon (iab) was opened before removing the stylet and was difficult to pass.As a result, a new iab was used.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the balloon of the intra-aortic balloon (iab) was opened before removing the stylet and was difficult to pass.As a result, a new iab was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint iab unwrapped prematurely is confirmed.The iabc central lumen was noted damaged/broken in the distal tip area upon receipt of the sample.A damaged/broken central lumen will result in difficulty of maintaining a vacuum on the iabc bladder.If a vacuum on the bladder is not maintained, it can result in a bladder to unwrap prematurely.The iabc bladder membrane passed functional testing.The root cause of the complaint is undetermined, but a potential cause is customer handling.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: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11589015
• MDR Text Key: 242930537
• Report Number: 3010532612-2021-00074
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F20H0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR