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

Model Number IPN000260

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the balloon was inflating and deflating appropriately, no alarms or signals noted.No difficulty with insertion through the sheath.The intra-aortic balloon pump (iabp) was pumping less than 10 minutes when blood appeared in the tubing and alarmed.As a result, the catheter was replaced using the same insertion site and there were no further issues.The aorta was not calcific or tortuous.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4), teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation of the returned device, blood was confirmed within the helium pathway.Upon return, there was combined findings including a damaged/broken central lumen, a damaged bladder distal tip and a leak site on the bladder.The combined damage can result in a helium pathway leak and cause blood to enter the helium pathway.Due to the combined damage and state of the device, it could not be determined which finding occurred first or what initially caused the complaint.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 risk.This will be monitored for any developing trends.

Event Description

It was reported that the balloon was inflating and deflating appropriately, no alarms or signals noted.No difficulty with insertion through the sheath.The intra-aortic balloon pump (iabp) was pumping less than 10 minutes when blood appeared in the tubing and alarmed.As a result, the catheter was replaced using the same insertion site and there were no further issues.The aorta was not calcific or tortuous.There was no report of patient complications, serious injury or death.

• 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: 12077013
• MDR Text Key: 258699118
• Report Number: 3010532612-2021-00164
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F21A0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1