MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC PT2 GUIDEWIRE; ENDOSCOPIC GUIDEWIRE GASTROENTEROGOLY-UROLOGY

Model Number 08714729471202

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/12/2018

Event Type  Injury  

Event Description

During a cardiac intervention, the tip of a guidewire was dislodged into the diagonal artery.Attempted to retrieve wire tip, attempts unsuccessful, wire tip remained.

• Brand Name: BOSTON SCIENTIFIC PT2 GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE GASTROENTEROGOLY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7609560
• MDR Text Key: 111447906
• Report Number: MW5077900
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Model Number: 08714729471202
• Device Catalogue Number: H7493893103J0
• Device Lot Number: 21346862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR