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

Model Number N/A

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Needle Stick/Puncture (2462)

Event Date 11/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "after 10 minutes of use of the intra-aortic balloon (iab) catheter the balloon of the catheter has holed." additional information received: at the end of the procedure it was difficult to remove the catheter because there was a coagulation on the tip.An intervention was performed a small cut to allow the extraction of the catheter.Surgical repair at access site.There was no reported patient death.Patient outcome reported as recovery.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab removal difficulty is not able to be c onfirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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.

Event Description

It was reported "after 10 minutes of use of the intra-aortic balloon (iab) catheter the balloon of the catheter has holed." additional information received: at the end of the procedure it was difficult to remove the catheter because there was a coagulation on the tip.An intervention was performed a small cut to allow the extraction of the catheter.Surgical repair at access site.There was no reported patient death.Patient outcome reported as recovery.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8079553
• MDR Text Key: 127423649
• Report Number: 3010532612-2018-00357
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• 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: 11/07/2018

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18S16J0018
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 65