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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Weight: 106.9kgs.Implanted date: device was not implanted.Explanted date: device was not explanted.A review of the device history record of the product code/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
The user facility reported that a sheath was used on a pacemaker case.The tip of the sheath broke off into patient and was not able to be retrieved.This was confirmed by x-ray.The patient was stable and okay.Procedure outcome was unknown, and it was unknown if they were able to finish the case.Additional information was received on 10 feb 2023: the tip was attempted to be removed by a wire and a snare through the left arm.Intravascular ultrasound (ivus) was used to enhance visualization.The tip was located by x-ray in the left subclavian vein.The cause of the tip breaking is undetermined.The procedure was competed.The account had no other issues while implanting the pacemaker.The estimated blood loss was 50cc.
Event or Problem Description
Additional information was received on 10 mar 2023: it was not the tip of the sheath that broke, however, it was the end of the 0.021 nitinol guidewire that comes in the kit that was retained in the patient, possibly from shearing and unravelling off the entry needle.The incident occurred while trying to pull the wire back through the entry needle.There was no tortuosity seen on imaging.Subclavian vein stick.At the time of incident, there was nothing else inserted into the sheath.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide additional information in section b5 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for guidewire separation because the x-ray provided by the account shows the sheered guidewire tip in the chest cavity.The exact root cause could not be determined.The likely root cause is the guidewire was withdrawn through the access needle causing the guidewire to sheer and separate.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 & effects analysis (dfmea).

• 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: 16510193
• Report Number: 1118880-2023-00017
• Device Sequence Number: 17538151
• Product Code: DYB
• UDI-Device Identifier: 00389701010885
• UDI-Public: 00389701010885
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 70-5165
• Device Lot Number: 0000258405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: PM2272 ABBOTT PACEMAKER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native