MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AMPLATZ SUPER STIFF GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number UNK531

Device Problems Entrapment of Device (1212); Device Abrasion From Instrument Or Another Object (1387)

Patient Problem Death (1802)

Event Date 11/22/2016

Event Type  Death  

Manufacturer Narrative

Date of birth: 1934.Device evaluated by manufacturer: 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).

Event Description

It was reported that post a tavi procedure, the patient expired.The patient presented with severe aortic stenosis and it was decided to perform a tavi procedure.A non-bsc valve was advanced through the tortuous and calcified aortic arch.While advancing the valve a blockage was encountered with the amplatz super stiff guide wire as there was an abrasion of the coating on the wire.The abrasion of the coating locked the mobility of the amplatz super stiff guide wire in the lumen of the carrier system of the non-bsc valve.The non-bsc valve could not be advanced further and was pulled back into the ¿bar¿ where an iliac perforation occurred.A new guide wire and non-bsc valve were then advanced and the valve was successfully implanted.The patient was taken to the intensive care unit in stable condition.A few hours later the patient experienced abrupt electromechanical decoupling and resuscitation attempts were unsuccessful.The autopsy report showed that the cause of death is due to a perforation in the area of the implanted non-bsc valve which appears in the heart sac with acute pericardial effusion.

• Brand Name: AMPLATZ SUPER STIFF GUIDEWIRE
• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6190834
• MDR Text Key: 62905009
• Report Number: 2134265-2016-11910
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K843012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death