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

Catalog Number IAB-05840-LWS

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the rn that they have a patient they brought to the cardiac cath lab (ccl) to remove an intra-aortic balloon (iab).The cardiologist was pulling the catheter out when he realized the tip had separated from the catheter and was retained in the femoral artery.They transferred the patient to the or for a surgical removal of the retained tip.The patient was hemodynamically stable and the removal of the tip was successful.Surgical removal of the tip of the iab was performed from the femoral artery.Surgery was reported successful.Patient current condition noted as fine.

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.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.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.No further action required at this time.

Event Description

It was reported by the rn that they have a patient they brought to the cardiac cath lab (ccl) to remove an intra-aortic balloon (iab).The cardiologist was pulling the catheter out when he realized the tip had separated from the catheter and was retained in the femoral artery.They transferred the patient to the or for a surgical removal of the retained tip.The patient was hemodynamically stable and the removal of the tip was successful.Surgical removal of the tip of the iab was performed from the femoral artery.Surgery was reported successful.Patient current condition noted as fine.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7429203
• MDR Text Key: 105416555
• Report Number: 3010532612-2018-00081
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17B0020
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 102