MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000257

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the cardiologist tried to implant the intra-aortic balloon (iab) it was noted that the balloon leak after insertion and blood was noted in the balloon.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the cardiologist tried to implant the intra-aortic balloon (iab) it was noted that the balloon leak after insertion and blood was noted in the balloon.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab: blood in helium pathway is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.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.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 when the cardiologist tried to implant the intra-aortic balloon (iab) it was noted that the balloon leak after insertion and blood was noted in the balloon.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, a leak was noted from the distal end of the bladder membrane.Furthermore, the leak was confirmed to be caused by the bladder tip not attached to the iab distal tip.No other leaks were detected.The root cause is undetermined.A non-conformance has been initiated to further investigate the issue.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.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10641548
• MDR Text Key: 210180378
• Report Number: 3010532612-2020-00287
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN000257
• Device Catalogue Number: IAB-06830-U
• Device Lot Number: 18F20D0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.; NI.
• Patient Age: 63 YR
• Patient Weight: 60