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 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion of the balloon, the artery got ruptured, leading to excess bleeding.As a result, a replacement catheter was used at the same insertion site, the femoral artery.There was no injury recorded or additional surgical intervention performed, and patient condition was reported as fine.Multiple attempts were made to clarify the event details but were unsuccessful.If additional information is received at a later date, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of iab insertion difficulty is confirmed based on the state of the returned sample.The iabc was returned with the bladder section withdrawn through the teflon sheath, but it could not be confidently determined whether the findings occurred prior to or during attempted insertion.The returned iabc passed functional testing, with no leaks noted.The returned state of the iabc, where the bladder was found withdrawn through the teflon sheath, the sheath tip was damaged and buckling was noted to the teflon sheath extrusion, indicates the iabc was not used correctly per the instruction for use (ifu).An in-service has been requested to review the instructions for use (ifu) with the customer.The root cause of the complaint is undetermined.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 revised risk.This will be monitored for any developing trends.Corrected data: additional information was received from the hospital that another catheter was not used.An artery rupture occurred and they had to use cover stent to stop the excessive bleeding.Based on this new information, the complaint has been updated to a serious injury.

Event Description

It was reported that during insertion of the balloon, the artery got ruptured, leading to excess bleeding.As a result, a replacement catheter was used at the same insertion site, the femoral artery.There was no injury recorded or additional surgical intervention performed, and patient condition was reported as fine.Multiple attempts were made to clarify the event details but were unsuccessful.If additional information is received at a later date, the complaint file will be updated.

• Brand Name: ULTRAFLEX IAB: 7.5FR 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: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 12853245
• MDR Text Key: 281091012
• Report Number: 3010532612-2021-00385
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: IPN000260
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F19K0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• 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