MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN039783
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number 3600840000-2022-8070.
Event or Problem Description
Complaint from medsun report: it was reported "early 60's female with history of diabetes, hypertensoin and acute chest pain.Procedure: cardiac cath, percutaneous intervention, stent placement and balloon angioplasty.While doing the procedure, the balloon would not inflate.Device removed and another one used without difficulty.No known harm to patient".
Additional Manufacturer Narrative
(b)(4).The reported complaint of iab would not inflate completely is not able to be confirmed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Additional information received stated that the "patient was discharged 02 aug 2022 without known issues from the device".
Event or Problem Description
Complaint from medsun report: it was reported "early 60's female with history of diabetes, hypertensoin and acute chest pain.Procedure: cardiac cath, percutaneous intervention, stent placement and balloon angioplasty.While doing the procedure, the balloon would not inflate.Device removed and another one used without difficulty.No known harm to patient".

• Brand Name: REDIGUARD IAB: 7FR 30CC
• Common Device Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15390464
• Report Number: 3010532612-2022-00360
• Device Sequence Number: 17546219
• Product Code: DSP
• UDI-Device Identifier: 10801902145649
• UDI-Public: 10801902145649
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN039783
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F21H0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 68 KG