MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Entrapment of Device (1212); Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Foreign Body Embolism (4439)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: retainedwire.A2: date of birth: requested, not provided.A5: ethnicity: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rtr cv lab manager.A review of the device history record of the product code and lot number combination was conducted with no findings.The actual device was not available for return; therefore, an evaluation of the actual device was unable to be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical received an fda medwatch report # mw5115543.The event description states: patient was admitted for outpatient interventional radiology (ir) for staged procedures.At the completion of the arteriogram, embolization prior to cryoablation, a small metallic foreign body was seen persisting in the region of intervention on review of imaging films.After cessation of the procedure, separate radiographs of the pelvis and right hip were obtained, as well as a focused ultrasound, demonstrating an apparent retained section of wire within the subcutaneous tissues.Superficial to the right femoral artery and vein, normal flow was established at the right common femoral artery and vein.Retrieval was felt to be more traumatic than the potential for complications, therefore no retrieval attempt was made at the time.Subsequent attempt to remove the foreign body later was unsuccessful.Additional information was received on 21 mar 2023: the broken wire was confirmed to still be within the patient.The date of the attempt to remove the wire was (b)(6) 2022.The patient was in stable condition.Additional information was received on 22 mar 2023: there was no harm to the patient's organs or vessels.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device has not been returned; therefore, an evaluation of the actual device was unable to be conducted.When the device is returned the complaint will be reopened.The complaint cannot be confirmed since the sample was not available for evaluation.The exact root cause cannot be determined.The likely root cause is there was resistance during guidewire removal that led to the breakage.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• 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: 16741340
• Report Number: 1118880-2023-00054
• Device Sequence Number: 6726833
• Product Code: DYB
• UDI-Device Identifier: 00389701010885
• UDI-Public: 00389701010885
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 02/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-5165
• Device Lot Number: 0000063334
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White