MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PT2 GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number UNK507

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

Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Vasoconstriction (2126)

Event Date 06/21/2013

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2013-04978 and 2134265-2014-01402.(b)(4).It was reported that distal spasm in right coronary artery (rca) occurred.In (b)(6) 2010, the patient presented with chest pain and was diagnosed with unstable angina and cardiac catheterization was recommended.Subsequently, the index procedure was performed.Target lesion #1 was a de novo lesion, located in the mid segment of saphenous vein graft (svg) artery to mid rca with 70% stenosis and was 15 mm long with a reference vessel diameter of 3.95 mm.Target lesion #1 was treated with pre-dilatation and placement of 3.00 x 28 mm taxus liberte stent.Following post dilatation, residual stenosis was 0.5 %.In (b)(6) 2013, the patient presented with recurrent cardiac chest pain and was diagnosed with angina.Subsequently, the patient was hospitalized on the same day.At the time of event, the patient was on aspirin where the last dosage was last taken on (b)(6) 2013.Cardiac catheterization was recommended.On the same day, the completely occluded 100% in-stent restenosis of study stent from svg to proximal rca was treated with balloon angioplasty and placement of a 3.0 x 22 mm promus element drug eluting stent, resulting in 0% residual stenosis.The following day, the patient developed chest pain so re-cath was recommended, which revealed a probable dissection induced by pt2 guidewires used in previous day's catheterization which resulted in spasm in distal rca.This spasm in distal rca was treated with administration of i.C.Nitroglycerin after which the area plumped up very well.Subsequently, the event was considered to be resolved without residual effects and the subject was discharged on aspirin and prasugrel.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was not returned for analysis as it was implanted.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

• Brand Name: PT2 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: 3690762
• MDR Text Key: 21733658
• Report Number: 2134265-2014-01403
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030617
• 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: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR