MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the head nurse that the event occurred during removal of the catheter from the patient.The intra-aortic balloon (iab) was inserted into the patient for 1 week and the doctor is recently removing the catheter.No alarm or abnormalities was found during indwelling time.The doctor removed the catheter with the sheath but encountered difficulty during removing.The front end of the catheter can't be removed.As a result, the doctor stopped the removal process and removed the catheter by artery incision.Patient outcome reported as fine.There was no report of patient death.

Event Description

It was reported by the head nurse that the event occurred during removal of the catheter from the patient.The intra-aortic balloon (iab) was inserted into the patient for 1 week and the doctor is recently removing the catheter.No alarm or abnormalities was found during indwelling time.The doctor removed the catheter with the sheath but encountered difficulty during removing.The front end of the catheter can't be removed.As a result, the doctor stopped the removal process and removed the catheter by artery incision.Patient outcome reported as fine.There was no report of 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 cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The root cause of how the blood entered the helium pathway 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.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7859385
• MDR Text Key: 119642831
• Report Number: 3010532612-2018-00278
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• PMA/PMN Number: K000729
• 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: 08/15/2018

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: 07/31/2019
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F17H0026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 64