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

Catalog Number IAB-S730C

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the insertion of the intra-aortic balloon (iab), the medical doctor was unable to advance the catheter through the spring wire guide (swg).He properly maintained the vacuum on the balloon and there was nothing special at that time.As a result, the failed catheter with sheath was removed together according to the instructions for use and replaced with another new iab successfully.There was no reported delay or interruption in therapy.There was also no patient complications or patient death reported.

Manufacturer Narrative

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

Event Description

It was reported that during the insertion of the intra-aortic balloon (iab), the md was unable to advance the catheter through the spring wire guide (swg).He properly maintained the vacuum on the balloon and there was nothing special at that time.As a result, the failed catheter with sheath was removed together according to the instructions for use and replaced with another new iab successfully.There was no reported delay or interruption in therapy.There was also no patient complications or patient death reported.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7145901
• MDR Text Key: 95845410
• Report Number: 1219856-2017-00315
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F16H0003
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1