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

Model Number IPN000263

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the staff inserted the sheath normally.When the intra-aortic balloon (iab) was inserted, the staff experienced that the iab was unable to pass through the guidewire and failed to pass through with repeated attempts.As a result, the iab was replaced and the new iab was able to pass.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 that the "iab was unable to pass through the guidewire and failed to pass through with repeated attempts" is confirmed.The returned intra-aortic balloon catheter (iabc) central lumen was found kinked and resistance was noted upon passing the guidewire through the iabc central lumen.The root cause of the kinked central lumen 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.

Event Description

It was reported that the staff inserted the sheath normally.When the intra-aortic balloon (iab) was inserted, the staff experienced that the iab was unable to pass through the guidewire and failed to pass through with repeated attempts.As a result, the iab was replaced and the new iab was able to pass.There was no report of patient complications, serious injury or death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11147102
• MDR Text Key: 226027781
• Report Number: 3010532612-2020-00403
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: IPN000263
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18H0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 74