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

Model Number 70-6160

Device Problems Material Fragmentation (1261); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2019

Event Type  malfunction  

Event Description

According to the physician's operative report, following positioning of the 5-fr arterial sheath in the right femoral artery, the physician next attempted to position the venous access.The micropuncture wire (the wire in question) was unable to advance into the femoral vein.While attempting to withdraw the wire from the site, the tip of the wire got stuck at the tip of the needle and then a small fragment of the wire was broken and stayed very likely above the vein under the subcutaneous tissue.An incision was made and extended to try to use a surgical instrument to grab the tip of the wire.They were able to extract most of the wire tip except for a small fragment which was lying very likely above the vein.An ultrasound was performed which revealed evidence of wire fitting in the intraluminal vein likely stuck under the subcutaneous tissue.A consultation was obtained with a vascular surgeon and determined that it was not necessary to extract the tip at that time.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8748062
• MDR Text Key: 149646490
• Report Number: 8748062
• Device Sequence Number: 1
• Product Code: DYB
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-6160
• Device Catalogue Number: 70-6160
• Device Lot Number: XE24
• 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: 06/13/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA
• Patient Weight: 46