MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY

Model Number 1012280-15

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2017

Event Type  malfunction  

Event Description

After final angioplasty, the balloon was withdrawn.It was noted the balloon embolized as it separated from the shaft.At that point, the left femoral arterial access was obtained.An over the wire long sheath was passed from the left femoral artery into the right common femoral.The embolized balloon was identified in the right superficial femoral artery (sfa) and with the help of a gooseneck snare, surgeons were able to safely capture and retrieve it.Bilateral groin accesses were closed with the angio-seal device.

• Brand Name: TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 6903999
• MDR Text Key: 87766510
• Report Number: 6903999
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 50727G1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 6-FRENCH SHEATH, 6-FRENCH FR4 GUIDING CATHETER, RU; CARDIAC DRUGS
• Patient Age: 71 YR
• Patient Weight: 101