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

Model Number	IPN038075
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "sheath dilator split at tip".The report states "could not get introducer to penetrate through skin.When the doctor pulled back he noticed the blue dilator was split at the tip." as a result, another iab was used and inserted at the same insertion site.There was no report of patient complications, serious injury or death.Patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The lot number reported is 18f22h0014.The lot number of the returned device is suspected to be from the reported lot; however, no original packaging/label was returned.Returned for investigation was an 8fr dilator from a semi-finished insertion kit for a 40cc ultraflex intra-aortic balloon catheter.Upon visual inspection, the tip was noted damaged/split; the appearance of the dilator tip is an inconsistent diameter with damage to the material at the tip opening.The dilator hub appeared typical.Dried blood was noted on the sample.No other damage or abnormalities were noted.The returned dilator could not be accurately measured due to the damage noted upon return.The dilator was aspirated and flushed successfully.Some dried blood was noted.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.The risk is acceptable.This will be monitored for any developing trends.The reported complaint of dilator tip damaged - found during use is confirmed.During the investigation, the dilator was noted damaged/split at the tip.The appearance of the dilator tip is an inconsistent diameter with damage to the material at the tip opening.The cause of the damage is undetermined.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the damaged dilator tip.The root cause of the complaint is undetermined.No further action required at this time.This will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
Reported as "sheath dilator split at tip".The report states "could not get introducer to penetrate through skin.When the doctor pulled back he noticed the blue dilator was split at the tip." as a result, another iab was used and inserted at the same insertion site.There was no report of patient complications, serious injury or death.Patient status is reported as "fine".

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16539383
• Report Number: 3010532612-2023-00165
• Device Sequence Number: 17945036
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: 00801902136695
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F22H0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 129 KG