MAUDE Adverse Event Report: MEDTRONIC, INC SITESEER (UNKNOWN); CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During catheterization of the rca the siteseer jr 4 6f catheter was deformed, resistance was experienced during use and could not be withdrawn through the sheath.Problem occurred due to tortuosity.Required surgical intervention.Nine days later stenting on rca occurred.

Manufacturer Narrative

Cine image review: the femoral and iliac arteries on the right side are tortuous.The lca looks difficult to engage but good images seen.The angio runs show a catheter torsioned in the iliac.No images of catheter in the rca were provided.The account reported that the device was twisted in the patient and detached.

• Brand Name: SITESEER (UNKNOWN)
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC INC.; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5305348
• MDR Text Key: 33717911
• Report Number: 1220452-2015-00068
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K932092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/04/2016; 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00073 YR
• Patient Weight: 100