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

Catalog Number IAB-S840C

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after successful puncture and arterial sheath insertion, the intra-aortic balloon (iab) catheter was inserted along the spring wire guide (swg) while it was found that the swg could not go through the end due to the central cavity having been blocked.As a result, a new iab was inserted and was reported successful.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab tight over guidewire is confirmed.Upon visual inspection, kinks were noted to the central lumen near the bifurcate.Upon inserting a guidewire, resistance was experienced at the locations of the kinks.The root cause of the kinks 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 revised risks.This will be monitored for any developing trends.This will be monitored for any developing trends.No further action required at this time.Other remarks:.

Event Description

It was reported that after successful puncture and arterial sheath insertion, the intra-aortic balloon (iab) catheter was inserted along the spring wire guide (swg) while it was found that the swg could not go through the end due to the central cavity having been blocked.As a result, a new iab was inserted and was reported successful.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7898807
• MDR Text Key: 121452941
• Report Number: 3010532612-2018-00289
• 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: 08/28/2018

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: 08/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17J0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR