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 No Consequences Or Impact To Patient (2199)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during intra-aortic balloon catheter (iabc) procedure, it was noted that the wire was unable to pass through the balloon in the cath lab.As a result, a new catheter was used successfully.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 tight over guidewire is confirmed.A damaged central lumen, consistent with being flattened, was discovered during the complaint investigation.Upon inserting the guide wire through the central lumen, resistance was experienced at the locations of the damaged central lumen.The root cause of the damaged central lumen 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.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iab bladder in the packaging tray.This damage indicates the iab was not prepped per the instructions for use (ifu) and can result in damage to the iab.An in-service has been requested to reiterate the ifu, including the appropriate method for iab prep/removal from its packaging.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.

Event Description

It was reported that during intra-aortic balloon catheter (iabc) procedure, it was noted that the wire was unable to pass through the balloon in the cath lab.As a result, a new catheter was used successfully.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: 9776064
• MDR Text Key: 183762276
• Report Number: 3010532612-2020-00056
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: 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: 02/28/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR