MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Catalog Number	54-54501
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned to the manufacturing facility 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 relevant findings.See mdr 1118880-2017-00030 for the second device reported.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 the valve was disconnected when the destination package was opened.Follow up communication with the user facility reported: attempted to screw valve down but would not "lock"; a second unit was opened and used; when the physician removed a catheter through the valve the valve "popped off"; the procedure was successful; and there was no impact to the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the evaluation results.The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and the review of the device history records.A review of the complaint handling database confirmed there have been no previous reports for this part/lot number combination; however, there have been 21 similar reports for this product family in the past three years.A review of the device history record for the reported lot and the ccv sub-assemblies confirmed there were no related issues during manufacturing.Based on the limited product information provided and no return of the complaint sample, no probable root cause could be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6525834
• Report Number: 1118880-2017-00029
• Device Sequence Number: 13859777
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: (01)00389701008912(17)190531(10)UP07
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K081046
• 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
• Report Date (Section B): 04/27/2017

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: 05/31/2017
• Device Catalogue Number: 54-54501
• Device Lot Number: UP07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1