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

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

Date of event - (b)(6) 2019, day not known.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned 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 findings.[(b)(4)].

Event Description

Terumo medical received a user facility medwatch report # (b)(4).The event description states: "according to the physicians operative report, following the positioning of the 5fr.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 in the femoral vein.While attempting to withdrawal 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 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.Original procedure was left heart catheterization and left ventricular angiogram.A formal consultation was subsequently performed following the cc procedure by the vascular surgeon and confirmed that the ultrasound showed normal flow through both the common femoral artery and vein, the wire fragment was in the subq space and no surgical intervention was required".Additional information was received on july 18, 2019.The patient was reported to be in stable condition.The fragment remained implanted in the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8816366
• MDR Text Key: 151875802
• Report Number: 1118880-2019-00182
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (y/n): N
• PMA/PMN Number: K111606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: XE24
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 46