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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).The actual device has not 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 a piece of the ik device sheath broke off inside the patients arm during the procedure.The doctor was successful retrieving and removing the broken piece at the end of the procedure.The patient was in stable condition.Additional information was received february 4, 2019: the procedure performed was a balloon angioplasty on the left arm.The broken piece was removed by a snare.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction and to provide the device return date.In the initial report the b4 section was advertently left blank.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide additional.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on march 19, 2019: the patient did not experience a vessel spasm during this event.The broken piece was removed without force.
Additional Manufacturer Narrative
This report is being submitted as follow up no.3 to update the device evaluated by mfr section and to provide the completed investigation results.One 7fr ik sheath was returned for product evaluation.A snare was returned along with the sheath.Visual inspection revealed that the entire sheath was returned separated from the hub and the snare used to remove the sheath from the patient was attached to it upon receipt.The tip of the sheath appeared to be deformed and flared out when visualized under the microscope.No other anomalies were noted with the sheath.The sheath hub was inspected microscopically to check for the caulking pin and it was found to be in the original manufacturing position as seen in the attached pictures.The sheath hub was carefully dissected to remove the caulking pin.The outer diameter of the straight and flared portion of the caulking pin was measured using a calibrated caliper.The outer diameter of the straight portion was found to be 3.53mm and the outer diameter of the flared portion was 4.49mm.Both the dimensions were within the manufacturer specification.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, is likely that the product was mishandled which resulted in the separation of sheath from the hub.However, the exact cause of the reported event cannot be definitely determined based on the available information.

• Brand Name: PINNACLE ROII HIFLOW INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8339498
• Report Number: 1118880-2019-00026
• Device Sequence Number: 206260
• Product Code: DYB
• UDI-Device Identifier: 00389701008325
• UDI-Public: 00389701008325
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K062446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2019

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSB705H
• Device Lot Number: VF03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 02/14/2019; 03/19/2019; 05/11/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/01/2019; 04/03/2019; 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 97