MAUDE Adverse Event Report: TERUMO MEDICAL CORP. TERUMO - FR 4; PINNACLE PRECISION ACCESS SYS

Catalog Number 70-4160

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

During vascular procedure, tip of wire broke seen by fluoroscopy in right sfa.Attempted to snare - unable to do.Cover stent deployed to stabilized piece of wire against wall of vessel.Guidewire 0.021" / 0.53mm nitinol, sheath length - 10 cm, needle size 21g taper.

• Brand Name: TERUMO - FR 4
• Type of Device: PINNACLE PRECISION ACCESS SYS
• Manufacturer (Section D): TERUMO MEDICAL CORP. ; 265 davidson ave. ; somerset NJ 08873
• MDR Report Key: 9214121
• MDR Text Key: 163301722
• Report Number: MW5090507
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 70-4160
• Device Lot Number: XE03
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR