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 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath.The swg was deformed, and the balloon was damaged.Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work.There was no patient death or serious injury or reported.Patient current condition reported as fine.

Event Description

It was reported there was big resistance when the intra-aortic balloon (iab) catheter was implanted along the spring wire guide (swg) into the sheath.The swg was deformed, and the balloon was damaged.Then replacing with another catheter, there was big resistance as well, but it can go into the body reluctantly, and the device began to work.There was no patient death or serious injury or reported.Patient current condition reported as fine.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of insertion difficulty is not able to be confirmed.The root cause of the complaint 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.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8080956
• MDR Text Key: 127551252
• Report Number: 3010532612-2018-00369
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17L0006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR