MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE KINETIX¿; WIRE, GUIDE, CATHETER

Model Number H74939122010

Device Problem Detachment Of Device Component (1104)

Patient Problems Hematoma (1884); Device Embedded In Tissue or Plaque (3165)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the returned product consisted of a kinetix guidewire.The shaft and the remainder of the device were checked for damage.The device showed a separated tip and was not returned per the customer¿s complaint.The missing section measured approximately 4.5cm long.This measurement was gathered from taking the length of a finished product and subtracting the returned product length and the remainder was the missing piece.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.(b)(4).

Event Description

It was reported that distal detachment occurred.The target lesion was located in the tortuous ramus branch coronary artery.A 185cm kinetix¿ guide wire was advanced but failed to cross the lesion.The device was removed without tension nor difficulty.However, upon x-ray, a small black speck was noticed in the vessel.The wire tip had broken off and was unable to be snared.The wire tip was stented against the vessel wall with another stent and the procedure was completed.The patient was initially stable for 4-6 hours post procedure but developed groin and retroperitoneal hematoma post-procedure probably due to leaving heparin on post-procedure.It was planned to turn off heparin in the morning.

• Brand Name: KINETIX¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6557576
• MDR Text Key: 74839750
• Report Number: 2134265-2017-04464
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: H74939122010
• Device Catalogue Number: 39122-01
• Device Lot Number: 17994727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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): Required Intervention