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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation: admin nurse iii.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 the catheter of a pinnacle device was inserted into the patient.When the catheter was manipulated it broke in half.The catheter was pulled out and the second piece had to be fished out and snapped in half.The outcome of the procedure was successful and the patient was in stable condition.Additional information was received 05 september 2019: the user facility stated that when they were manipulating the device that meant moving it back and forth within the patient.Once the device broke it was removed from the patient and nothing was left in the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update the h3 section and to provide the completed investigation results.One 5 fr introducer sheath in two pieces was received for product evaluation.The dilator was returned as well.The sheath was in two pieces and broken midway in the shaft.Upon analyzing the broken ends under a microscope, it was seen that the cut edges were clean, uniform and sharp.There were no jagged edges on piece and on the other piece the cut was clean until the end where it seemed to have under plastic deformation due to a pulling force.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the sheath came into contact with a sharp blade.However, the exact cause of the reported event cannot be definitely determined based on the available information.

• Brand Name: PINNACLE RO II INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9089807
• Report Number: 1118880-2019-00244
• Device Sequence Number: 2819847
• Product Code: DYB
• UDI-Device Identifier: 00389701009308
• UDI-Public: 00389701009308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSB501
• Device Lot Number: XF0813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: 88 YR