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

Model Number	RSS901
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Introducer sheath arterial dilators - blood poured out of hemostasis valve - explanted and replaced.Tavr procedure successfully performed.Patient to icu in stable condition.9 fr sheath placed in patient's body.Once the dilator for the sheath was removed, we realized the diaphragm for the sheath was broken and arterial blood was squirting out the sheath.We replaced the whole sheath with another 9 fr sheath, and it started leaking as well, but not quite as bad.

• Brand Name: PINNACLE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton boulevard; elkton MD 21921
• MDR Report Key: 9665290
• Report Number: 9665290
• Device Sequence Number: 3445131
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: (01)00389701007281
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/06/2019
• Report Date (Section F): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RSS901
• Device Catalogue Number: RSS901
• Device Lot Number: WG20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84
• Date Report Sent to FDA: 12/06/2019