MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE ROII HIFLOW INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Height: 5'6".D10: ref# (b)(4) lot#regz1294.E3: occupation: lead tech.A review of the device history record of the product code and lot number combination was conducted with no findings.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The user facility reported that there was a crack noticed at the hub of the sheath during the procedure once the balloon was removed after inflation.A conquest 40 balloon size 12mm x 40mm was used.The procedure being performed was a right harm fistula angioplasty.The patient was stable and the stable.Procedure successful.Additional information was received on (b)(6) 2023: the crack is in the white part of the sheath at the base of the hub.The procedure was completed with the same sheath.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.One ik sheath was returned for assessment.The sample was subject to visual analysis.The sheath is damaged at the base of the hub.The damage appears to be a kink in the sheath.The sheath tip is deformed.The sheath was measured and is 4cm in length from the sheath hub.There is no crack at the base of the sheath hub.X-ray images were taken of the sheath hub.The caulking pin is in place.The marker band on the sheath tip is still intact.The x-ray shows widening of the sheath tip and damage to the tip.The complaint can be confirmed for sheath damage.The exact root cause could not be determined.The likely root cause of the sheath damage at the hub is the bard conquest 40 balloon is incompatible with the 7fr sheath used during the procedure, making it difficult to remove the balloon and damaging the sheath in the process.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: PINNACLE ROII HIFLOW INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16915518
• Report Number: 1118880-2023-00084
• Device Sequence Number: 6423379
• Product Code: DYB
• UDI-Device Identifier: 00389701008295
• UDI-Public: 00389701008295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 03/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSB704H
• Device Lot Number: 0000236530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BARD CONQUEST 40 BALLOON SIZE 12MM X 40MM.
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic
• Patient Race: White