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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 during a procedure the conquest balloon was passed through the involved ik sheath and inflated in the subclavian vein.At first the balloon appeared to pop and was reported to be removed without difficulty.A second conquest balloon was then advanced, during the inflation of the balloon it was discovered that the sheath was on the wire distal to the balloon.The balloon was removed and the wire with the sheath on it was left in the patient and secured to the access site.An ambulance was called, and the patient was transferred to a hospital where the foreign body retrieval procedure was performed.The removal of the sheath was successful.The original procedure was a right arm fistulagram with intervention and angioplasty of the subclavian vein.The corrective procedure was a foreign body retrieval via the left femoral vein.Patient condition was stable and planned to be discharged home.The procedure outcome was successful foreign body retrieval.The event occurred intra-operative.The patient required medical or surgical.Additional information was received on 05 april 2023: the sheath piece that required to be surgical removed from the patient was an entire 4cm in length.It separated from the orange hub.No resistance was encountered during removal of the sheath.There were no difficulties inserting the sheath into the patient.
Additional Manufacturer Narrative
One ik sheath and bard conquest 40 balloon were returned for assessment.The sample was subject to visual analysis.The balloon is inserted into the 7fr sheath hub.The sheath is completely separated from the sheath hub.The broken sheath is 6.4cm in length.The sheath tip is deformed.The sheath end that was attached to the sheath hub is bent and folded onto the sheath.X-ray images were taken of the sheath hub.The caulking pin is dislodged.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 separation because the returned sample is separated at the hub.The exact root cause could not be determined.The likely root cause of the sheath separation is the bard conquest 40 balloon is an 8fr and the terumo sheath is a 7fr.Using a balloon larger than the sheath would increase resistance during retrieval, leading to separation.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: 16865684
• Report Number: 1118880-2023-00064
• Device Sequence Number: 5478298
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/02/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White