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

Catalog Number IAB-S840C

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the guard of the catheter fell off from the wing protection when the patient turned over and the catheter was exposed and contaminated.It was also reported that there was big resistance when the catheter was implanted along the spring wire guide (swg) into the sheath.As a result, the catheter was removed.Patient outcome reported as fine.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use, the guard of the catheter fell off from the wing protection when the patient turned over and the catheter was exposed and contaminated.It was also reported that there was big resistance when the catheter was implanted along the spring wire guide (swg) into the sheath.As a result, the catheter was removed.Patient outcome reported as fine.There was no report of delay in therapy.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that "the catheter fell off from the wing protection" 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: 8261476
• MDR Text Key: 133554349
• Report Number: 3010532612-2018-00422
• 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: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• 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: 02/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR