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

Model Number IPN000254

Device Problem Entrapment of Device (1212)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the cardiac cath lab manager that upon removal of the intra-aortic balloon (iab), entrapment was discovered upon removal.The iab was "stuck" in the leg and vascular surgery was consulted for removal.The catheter was removed without further complications.It was described as a "knot on the central shaft of the balloon itself".The patient was stable and did not require iab support.The iab required surgical removal by a vascular surgeon.There was no report of patient death.

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 confirmed.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 by the cardiac cath lab manager that upon removal of the intra-aortic balloon (iab), entrapment was discovered upon removal.The iab was "stuck" in the leg and vascular surgery was consulted for removal.The catheter was removed without further complications.It was described as a "knot on the central shaft of the balloon itself".The patient was stable and did not require iab support.The iab required surgical removal by a vascular surgeon.There was no report of patient death.

• 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: 9559220
• MDR Text Key: 173967408
• Report Number: 3010532612-2019-00466
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F19K0026
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention