MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE R/OII HIFLOW INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a fisulagram procedure, a 7fr x 4cm pinnacle sheath was used with a 14mm x 40mm atlas pta balloon.This balloon was inflated, removed and an angiogram was taken.The same balloon was then reinserted and used again.Upon removing the atlas pta balloon, the physician noticed that the sheath came apart at the hub.The distal end of the sheath was still on the wire inside the patient's artery.A snare was used to remove the loose piece of the sheath.The patient (pt) was able to recover and left the department with no issues.The patient was in stable condition.The procedure was a success.The estimated blood loss was less than 250cc.Additional information was received on 18 jul 2022: there was no additional testing other than the angiogram performed during the procedure.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.One 7fr ik was returned for product evaluation.The returned device include the sheath.The returned device was subjected to visual analysis.The hub was completely separated from the sheath shaft.There was some tension-related stretching seen at the hub end of the sheath.The sheath shaft did not show any signs of tears.X-ray images were taken of the sheath.The caulking pin was intact and in the correct position.The marker band on the sheath tip.Sheath tip x-ray showed some widening at the sheath tip.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is there was resistance which caused the sheath to separate from the hub.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 & effects analysis (fmea).

• Brand Name: PINNACLE R/OII 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: 15210238
• Report Number: 1118880-2022-00065
• Device Sequence Number: 17343457
• Product Code: DYB
• UDI-Device Identifier: 00389701008295
• UDI-Public: 00389701008295
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 08/11/2022

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSB704H
• Device Lot Number: YC19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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: AMPLATZ WIRE; ATLAS PTA BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown