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

Model Number	70-6160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported an issue with a pinnacle precision nit kit during a venogram for thrombectomy.The issue was wire breaking during access; the distal tip detached and was in the artery.The doctor managed to locate and retrieved the wire tip.The patient remained stable; the procedure was completed without further medical interventions.Additional information was received on 26 jul 2024: the physician snared the wire tip.It is unknown if there was calcium or stenosis present.The doctor said that the iliac bifurcation was very calcified.
Additional Manufacturer Narrative
A3b: gender: n/a.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: lot #: requested, unknown.D4: expiration datei: unknown, as the involved product lot # was unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown, as the involved product lot # was unknown.The actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The production lot # was not provided by the user facility, which prevented a meaningful review of the device history record.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 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 cannot be confirmed for guidewire separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is the guidewire was attempted to be withdrawn in the face of resistance due to calcification in the iliac bifurcation, as stated in the complaint description.It is possible the guidewire tip stuck in the calcification and separated during withdraw.Additionally, if the guidewire was withdrawn through the access needle, the guidewire could catch on the needle tip and separate.The ik precision instructions for use (ifu) was reviewed, and it states: "caution: advance the mini guidewire slowly.If resistance is met, do not advance or withdraw the mini guidewire until the cause of the resistance is determined." review of device history record (dhr) cannot be completed due to the unknown lot number.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• 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 ; 4103927218
• MDR Report Key: 20058140
• Report Number: 1118880-2024-00119
• Device Sequence Number: 7783741
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Model Number: 70-6160
• Device Catalogue Number: 70-6160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/24/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 6 FR PROCEDURAL SHEATH & SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female