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

Catalog Number IAB-05840-LWS

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck.The md pulled on the catheter and the patient suffered a femoral tear.The patient was operated on and he is currently doing fine.Once the balloon was removed, it was noticed that inside the balloon was foreign substances.Medical intervention was required to repair the femoral tear.There was no reported patient death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of removal difficulty is confirmed.The iab was returned with a damaged bladder consistent with removal difficulty.During the investigation, blood was confirmed within the iab helium pathway.The blood found within the bladder membrane could have potentially led to removal difficulties through entrapment.Due to the damaged state of the iab upon return, the original cause of the leak was unable to be determined.The root cause of how blood entered the helium pathway is undetermined.A device history record (dhr) review was conducted for the lot number/serial 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 developing trends.No further action at this time.

Event Description

It was reported that upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck.The md pulled on the catheter and the patient suffered a femoral tear.The patient was operated on and he is currently doing fine.Once the balloon was removed, it was noticed that inside the balloon was foreign substances.Medical intervention was required to repair the femoral tear.There was no reported 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
• 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: 7180390
• MDR Text Key: 96906638
• Report Number: 1219856-2018-00012
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: 03/31/2019
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F17C0040
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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