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

Model Number IPN000263

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was implanted normally, and the intra-aortic balloon pump (iabp) was started.The iabp could not be started and alarmed for a "helium leak".The iab was repositioned repeatedly, and the balloon size was adjusted, with no change.As a result, the iab was removed and a new iab was used, using the same insertion site.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the intra-aortic balloon (iab) was implanted normally, and the intra-aortic balloon pump (iabp) was started.The iabp could not be started and alarmed for a "helium leak".The iab was repositioned repeatedly, and the balloon size was adjusted, with no change.As a result, the iab was removed and a new iab was used, using the same insertion site.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab leak suspected is confirmed.During the investigation, a puncture to the bladder, consistent with contact from a sharp object, was found on the bladder membrane which caused the helium loss alarm and could allow blood to enter the helium pathway.No other leaks were detected during functional testing.The root cause of the bladder leak is undetermined.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: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10548909
• MDR Text Key: 207393295
• Report Number: 3010532612-2020-00253
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F20A0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 64