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

Model Number	RSS602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical obtained an fda medwatch report # mw5157015.The event description states that sheath & catheter became kinked during heart catheterization requiring vascular surgeon intervention to eliminate.
Additional Manufacturer Narrative
A1: patient identifier: requested, unknown.A2: age or date of birth: requested, unknown.A3a: sex: requested, unknown.A3b: gender: n/a.A4: weight: requested, unknown.A5: ethnicity: requested, unknown.A6: race: requested, unknown.B3: date of event: requested, unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: establishment name: requested, unknown.E1: establishment address: requested, unknown.E1: reporter name : requested, unknown.E1: phone number: requested, unknown.E2: health professional: requested, unknown.E3: occupation: requested, unknown.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; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
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 a sheath kink because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.Field clinical was contacted about this complaint and stated it is unlikely the sheath kink was the main cause of the sheath getting stuck, requiring surgical intervention.It is likely the sheath kinked during withdraw and led to a catheter or guidewire getting stuck in the sheath, preventing removal from the vessel.It is also possible the user encountered resistance from tortuosity or calcification in the vessel during withdraw that prevented removal of the sheath.Review of device history record (dhr) showed there were no issues noted during the 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 hazard based risk table (hbrt).

• Brand Name: PINNACLE
• 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: 20155592
• Report Number: 1118880-2024-00131
• Device Sequence Number: 4235816
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: (01)00389701007472(17)260601(10)0000471569
• Combination Product (Y/N): N
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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 Expiration Date: 06/01/2026
• Device Model Number: RSS602
• Device Catalogue Number: RSS602
• Device Lot Number: 0000471569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American