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

Catalog Number IAB-S840C

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was being advanced through the sheath and was noted that the iab was stuck and could not advance or be removed.The iab was then removed together with the sheath, which caused patient femoral artery injury, and sutured by the blood vessel surgery operation.As a result, a new catheter was used, and a second attempt was made on the opposite side of the patient at a new puncture site was successful.There was a report of delay in therapy.There was no report of patient death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab catheter stuck in sheath is confirmed based on visual inspection.Upon return, a teflon sheath was noted stuck on the iab and the sheath does not match the specifications for the sheath supplied with the iab.It cannot be determined that an incorrect sheath was supplied or if the correct supplied sheath was replaced after opening the package.The root cause of the complaint is undetermined.A review of the device history record (dhr) and quality inspections showed that this lot number was released with no component or insertion kit issues, as well a 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 the intra-aortic balloon (iab) was being advanced through the sheath and was noted that the iab was stuck and could not advance or be removed.The iab was then removed together with the sheath, which caused patient femoral artery injury, and sutured by the blood vessel surgery operation.As a result, a new catheter was used, and a second attempt was made on the opposite side of the patient at a new puncture site was successful.There was a report of delay in therapy.There was no report of patient death.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8874451
• MDR Text Key: 153691254
• Report Number: 3010532612-2019-00246
• Device Sequence Number: 1
• Product Code: DSP
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F18G0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR