MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) FIGHTER; CATHETER, GUIDEWIRE

Model Number	H749393031902
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059)
Date of Event	06/08/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).
Event or Problem Description
Same case as mdr id: 22134265-2017-06938, 134265-2017-06679, and 2134265-2017-06948.It was reported that guidewire fracture, vessel occlusion, myocardial infarction and death occurred.The patient presented with ostial circumflex (cx) disease.A fighter guidewire was advanced into the vessel.A 3.0x20mm synergy drug eluting stent was advanced and deployed in the left main (lm) artery into the cx.An 8f guide catheter was advanced further into the vessel and subsequently longitudinally deformed the deployed 3.0x20mm synergy stent.The deformed stent trapped the fighter guidewire in the stent structure.Subsequently the fighter guidewire fractured.The trapped portion remained in the vessel.Two synergy stents sizes 3.0x12mm and 4.0x16mm were deployed in the vessel to cover the deformed stent.The procedure ended and patient left the catheterization lab without further complication.Eight days later the patient presented to the emergency department of another hospital with an acute st segment elevation myocardial infarction (stemi).Angiography revealed the lm had closed off in the mid segment.There was no visualization of the left anterior descending (lad) or cx arteries.The type of occlusion was not stated.The surgeons were called immediately.The patient was intubated and iabp was placed.The patient was sent to surgery.The next day the patient expired.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6686132
• Report Number: 2134265-2017-06939
• Device Sequence Number: 992925
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: (01)08714729886617(17)20200224(10)0020332244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2020
• Device Model Number: H749393031902
• Device Lot Number: 0020332244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 69 YR