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 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on a patient of 177cm in height after puncture, the spring wire guide (swg) could not pass through the catheter therefore the intra-aortic balloon was not inserted.The catheter was replaced with a new one.Patient outcome: fine.There was no reported death or patient complications.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "swg can't pass through the catheter" is confirmed.The iab was returned with the packaging tray arrow sticker missing/damaged, which indicates the iab was not prepped correctly per the ifu.The iab was noted with damage consistent with not being prepped successfully.The iab central lumen was noted kinked and bent which caused guidewire insertion difficulty.The cause of the complaint is a result of improper prep per the ifu.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.

Event Description

It was reported that on a patient of 177cm in height after puncture, the spring wire guide (swg) could not pass through the catheter therefore the intra-aortic balloon was not inserted.The catheter was replaced with a new one.Patient outcome: fine.There was no reported death or patient complications.

• 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: 7139989
• MDR Text Key: 95627118
• Report Number: 1219856-2017-00312
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17D0052
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 71