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

Model Number RSS901

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/04/2019

Event Type  malfunction  

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton boulevard; elkton MD 21921
• MDR Report Key: 9665290
• MDR Text Key: 177634240
• Report Number: 9665290
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: (01)00389701007281
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSS901
• Device Catalogue Number: RSS901
• Device Lot Number: WG20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 84