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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.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.For this reason, evaluation code has been referenced in the conclusions.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 ik sheath was kinked before coming out of the package.The package looked like it had never been opened.The case was a peripheral leg case.The patient was reported to be in stable condition.The procedure was completed successfully with another sheath.Additional information was received on (b)(6) 2018.A second terumo sheath was opened and used to complete the case successfully.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.One 5fr sheath and dilator were returned for evaluation.The sheath and dilator were returned in their original manufacturing positions in the original packaging.The packaging had been opened as the seals were not intact.The sheath and the dilator were removed from the original packaging.The sheath was visibly kinked 7.2365" from the distal tip, and, after removal from the sheath, the dilator was visibly kinked 3.3885" from the distal tip.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 application of off axis forces may have caused the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and update.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.

• 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: 8069342
• Report Number: 1118880-2018-00169
• Device Sequence Number: 16558610
• Product Code: DYB
• UDI-Device Identifier: 00389701009322
• UDI-Public: 00389701009322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/14/2018

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: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSB503
• Device Lot Number: WD3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 11/27/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 11/16/2018; 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1