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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Chest Pain (1776); Pleural Effusion (2010); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Patient: 5ft tall.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.
Event or Problem Description
The user facility reported that during the during a procedure, the pinnacle ro ii introducer access catheter tip separated from the catheter and traveled to the patient's chest.The catheter tip could not be removed.The patient's condition was stable, and the procedure was a success.At the time surgical or medical intervention was not required.Additional information was received 05mar2020.The procedure performed was a shunt study.The device was used to complete the procedure.Testing was performed to confirm the tip remained in the patient's chest.Medical or surgical intervention was attempted for retrieval, with no luck.Additional information was received 06mar2020.The provider attempted a transcatheter retrieval of the foreign body which started out in the inferior right atrium.A 5fr tulip retriever was utilized.The sheath tip was taken by the blood to the pulmonary artery and was lodged.A grollman catheter was then selected and was loaded with a braided guidewire to the level of the lodged sheath tip.Several attempts were made to retrieve with no success.Fluoroscopy images were obtained documenting location of the tip.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, to update section h3, and to provide the completed investigation results.One used 7fr pinnacle roii sheath was received for product evaluation.No other accessory components were returned.Visual inspection revealed no kinks or bends on the surface of the sheath.However, the tip along with the marker band separated from the sheath shaft, both of which were not returned for evaluation.The sheath shaft length measured at 94 mm and 6 mm of the shaft tip was not received.The outer diameter of the sheath measured at 3.11 mm and the inner diameter of the sheath measured at 2.54 mm which is within manufacturer specifications.No other anomalies were noted with the returned components.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.Terumo is further investigating the reported event.
Event or Problem Description
Additional information was received on 23apr2020.There was no manipulation or damage noted to the tip of the sheath prior to insertion.The patient had no central venous stenosis, patient had excellent vascular flow.The physician felt the tip separated from the sheath when checking if there was stenosis was present.However, the doctor noted that the distal tip of the sheath had come off.They tried to retrieve it several times with no success.There have been no events since that day with the patient.There were no unusual forces applied to the sheath shaft.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide additional information in sections b5., b6., and h6.Patient codes and conclusion code.Terumo has determined the reported event to be manufacturing related and is being further investigated.
Event or Problem Description
Additional information was received on (b)(6)2020.The patient had returned for additional imaging.On (b)(6)2020 he had a portable chest x-ray performed for hypotension.On the same day, he again had a chest x-ray performed after the insertion of a central line.On (b)(6)2020 the patient returned for the removal of the ij tunneled hemodialysis catheter with no complications.On (b)(6)2020 the patient was admitted to the hospital for shortness of breath and chest pain.He was scheduled for a ct angio chest looking for pulmonary embolus.He was found to have bilateral pleural effusions with associated atelectasis.Additional information was received on (b)(6)2020.The doctor stated that the patient has not been back for a follow up declot procedure.The doctor anticipates that the tip of the sheath will have a fibrin sheath formed over it and grow into the wall where it is lodged with no complications.

• Brand Name: PINNACLE RO II INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 9897994
• Report Number: 1118880-2020-00082
• Device Sequence Number: 16747992
• Product Code: DYB
• UDI-Device Identifier: 00389701009148
• UDI-Public: 00389701009148
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSB712
• Device Lot Number: XM1613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 06/04/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/07/2020; 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARGON CLEANER; CONQUEST BALLOON; FOGARTY CATHETER; MUSTANG BALLOON; TERUMO GLIDEWIRE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Weight: 45