MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. NARROWFLEX IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN038075
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) was being removed from the patient, the staff noticed that the cuff was broken out and blood was noted in the cuff.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) was being removed from the patient, the staff noticed that the cuff was broken out and blood was noted in the cuff.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, blood was confirmed within the iab helium pathway.The cause of how the blood entered the helium pathway was unable to be determined due to the returned state of the device.The returned iab was too damaged to analyze.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 revived risk.This will be monitored for any developing trends.

• Brand Name: NARROWFLEX IAB: 8FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9859855
• Report Number: 3010532612-2020-00066
• Device Sequence Number: 2874195
• Product Code: DSP
• UDI-Device Identifier: 00801902002648
• UDI-Public: 00801902002648
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K021462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 07/31/2021
• Device Model Number: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F19H0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/18/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1