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 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the spring wire guide (swg) on the intra-aortic balloon (iab) couldn't pass through the catheter, after inserted into the sheath. Therefore the catheter was removed and changed for a new catheter. There was no patient death, serious injury, or complication reported. Patient current condition reported as fine.

Manufacturer Narrative

(b)(4). Teleflex received the device for investigation. The reported complaint that the "swg couldn't pass through the catheter" is confirmed. Upon inspection, the central lumen was found damaged with kinks and flattened features. Upon inserting a guidewire, resistance was experienced at the location of the kinks. The root cause of the kinks 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 the spring wire guide (swg) on the intra-aortic balloon (iab) couldn't pass through the catheter, after inserted into the sheath. Therefore the catheter was removed and changed for a new catheter. There was no patient death, serious injury, or complication reported. Patient current condition reported as fine.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7922701
• MDR Text Key: 122197095
• Report Number: 3010532612-2018-00300
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F17K0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No