MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) LUGE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number UNK496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 12/17/2010

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that chest pain occurred.On unspecified date, the patient was diagnosed with stable angina and cardiac catheterization was recommended.Subsequently, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in the distal left circumflex (lcx) with 80% stenosis and was 15mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct stent placement using a 2.50 mm x 2mm taxus® liberté® stent.Following post dilatation, residual stenosis was 0%.The target lesion #2 was a de novo lesion located in the 1st obtuse marginal (om) with 95% stenosis and was 15mm long with a reference vessel diameter of 3.5 mm.The target lesion #2 was pre-dilated with the balloon of the 2.5 x 28mm stent followed by placement of a 3.50 x 24 mm taxus® liberté® stent.Following post dilatation, residual stenosis was 0%.The target lesion #3 was a de novo lesion located in mid left anterior descending (lad) artery with 99% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.A 182 cm luge guide wire was crossed in the lesion.However, the patient was noted to have chest pain which was treated with 50 mcg of fentanyl.The lesion was then treated with pre-dilation and placement of a 2.50 x 16mm taxus® liberté® stent.Following post dilatation, residual stenosis 0%.One day post procedure, the patient was discharged on aspirin and prasugrel.

Manufacturer Narrative

Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: LUGE GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4106993
• MDR Text Key: 4699975
• Report Number: 2134265-2014-05602
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR