MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-S730C

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of an intra-aortic balloon (iab) catheter the balloon was stuck in the compatible sheath provide with the balloon.The medical doctor was not able to introduce or withdraw the iab.As a result, the iab was removed and another iab was used.There were no reported patient complications or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint that the catheter was stuck in the sheath is confirmed.Upon return, the iab was stuck in the returned sheath; however, the sheath was able to be removed from the iab.The bladder was noted fully unwrapped.The iab bladder and sheath passed dimensional specifications.The root cause of how the iab became stuck in the sheath 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.No further action required at this time.

Event Description

It was reported that during insertion of an intra-aortic balloon (iab) catheter the balloon was stuck in the compatible sheath provide with the balloon.The medical doctor was not able to introduce or withdraw the iab.As a result, the iab was removed and another iab was used.There were no reported patient complications or death.

• Brand Name: REDIGUARD IAB: 7FR 30CC
• 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: 7162296
• MDR Text Key: 96367143
• Report Number: 1219856-2017-00334
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F16E0055
• Other Device ID Number: 00801902002686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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
• Patient Age: 65 YR
• Patient Weight: 65