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

Model Number IPN000260

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blood was found in the helium driveline tubing of the intra-aortic balloon (iab) during use on a patient.As a result, a new catheter was used.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 the helium pathway is confirmed.A break in the central lumen was noted near the proximal end of the iab catheter, which can cause blood to enter the helium pathway.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.This damage indicates the iabc was not prepped correctly per the ifu and can result in damage to the iabc.An in-service has been requested to reiterate the instructions for use (ifu), including the appropriate method for iabc prep/removal from its packaging.The root cause of the broken central lumen is undetermined, but a potential cause is customer handling.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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that blood was found in the helium driveline tubing of the intra-aortic balloon (iab) during use on a patient.As a result, a new catheter was used.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that "blood was found in the helium driveline tubing" is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned later, a full investigation of the sample will be completed.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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 that blood was found in the helium driveline tubing of the intra-aortic balloon (iab) during use on a patient.As a result, a new catheter was used.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: 9858724
• MDR Text Key: 184472660
• Report Number: 3010532612-2020-00063
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F18D0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 71