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	08/23/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user facility reported that the pinnacle sheath distal tip of the ik 5fr dilator sheared off.It was a smooth separation as if it were cut.The tech noticed before loading on the wire; she had attempted to load on the wire; however, had not.The case was a leg angio performed by the doctor.A second sheath was requested and opened.The procedure was continued and completed without delay or injury.The device never touched the patient, their condition was reported to be unknown.Additional information was received on 29aug2019.The patient was reported to be in stable condition.
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 5fr glidesheath slender sheath and dilator were received for product evaluation.Visual inspection of the dilator revealed damage at the distal tip of the dilator.Microscopy confirmed that a small fragment of the dilator tip had broken off; the fragment was not returned for analysis.The crosscut valve was dissected and observed under microscope; no damage was seen on the valve.The sheath inner lumen at the hub was viewed under microscope and no damage was seen.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the dilator tip hit a hard surface and damaged the dilator.However, the exact cause of the reported event cannot be definitively 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: 9075805
• Report Number: 1118880-2019-00250
• Device Sequence Number: 19625457
• Product Code: DYB
• UDI-Device Identifier: 00389701009315
• UDI-Public: 00389701009315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSB502
• Device Lot Number: XG1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR