MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER CATHETER

Catalog Number	70-5160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing facility but the investigation is not yet complete.A follow up report will be submitted when the investigation is complete but no later than 30 days from the date that this report was sent.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported shearing of the wire tip on the involved device.Follow up communication with the user facility confirmed the following information: during access the doctor felt resistance when advancing the wire and pulled back to get a different angle; the wire became resistant to come back; the doctor decided to remove the needle and wire together; when removed, it was noticed that the wire was sheared off at the tip; fluoro of the groin showed that the wire was present but was not intravascular; the procedure was completed successfully with a small incision under fluoro where the wire was removed; post fluoro showed no wire present; blood loss was less than 250ml; and there was no harm to the patient, just prolonged the case.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section "a" as well as the sample evaluation results.Results = is based on evaluation of the returned sample; is based on the retention samples evaluated.Conclusions = is based on evaluation of the returned sample; is based on the retention samples evaluated.The needle and wire were returned to the manufacturing facility for evaluation.The needle revealed no visual defects.The tip of the wire was noted to be missing and the over-coil was coming off the core wire at the distal end of the wire.The proximal end of the wire was able to pass through the needle.An evaluation of the retention samples from the reported and surrounding lots manufactured was conducted.A visual inspection revealed no visual defects.Functional testing confirmed the products met manufacturing specification.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation the retention samples were found to be normal product and the return sample supports the claim that the wire met resistance and could not be withdrawn.Although the exact cause cannot be definitively determined based on the available information, the cause of the wire damage and the wire breaking is likely due to the wire being pulled back through the metal needle cannula.The device labeling does address the potential for such an event in the instructions-for-use, which states the following: "when using metal needle cannula do not withdraw the guidewire back into the cannula, as shearing of the guidewire may result." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the medwatch report number, mw5062708 that was received from the fda on june 27, 2016.Please see the initial and first follow up report for the event investigation details.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 5654001
• Report Number: 1118880-2016-00170
• Device Sequence Number: 350607
• Product Code: DYB
• UDI-Device Identifier: 00389701009162
• UDI-Public: 00389701009162
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2016

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: Physician
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 70-5160
• Device Lot Number: UA13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/15/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/13/2016
• Supplement Report FDA Received Date: 06/06/2016; 07/08/2016
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 106