MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TRUEPATH¿; WIRE, GUIDE, CATHETER

Model Number H74939208181650

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device rotated with no audible sounds of resistance heard.The approximately 250-300mm chronic total occlusion (cto) target lesion was located in the left superficial femoral artery (sfa).Angiogram was performed in the lower extremity and revealed a long cto of the left sfa.A 2cm nub was seen at the ostium of the sfa proximal to where the cto started.Originally the lesion was attempted to be crossed with a wire and a non bsc crossing catheter but this was unsuccessful and both the wire and catheter seemed to have gone to the subintimal at the proximal cap.Then, a truepath¿ cto device has been elected to be used to attempt crossing the lesion.The device was prepped and turned on outside patient¿s body at it appeared working properly.The device was then introduced into a 0.018 non bsc catheter.Once the device was in the body and just proximal to the proximal cap, the device was then activated.As the physician was moving the device distally through the lesion, the activation light illuminated.However, the second and third light never lit up, so it was suspected that the device was not meeting any resistance inside the cto and no sound was heard.An attempt to use the device some more was made and still no signs of resistance was noted.It was then suspected that the device was not working correctly.The device was turned off and removed from the body.Once the device was out of the body, the device was again tested.This time when the device was activated, it didn't seem like it was running at full power and when the tip was place against the doctors hand, the indicator light never lit up showing resistance.At this point, the device was set aside and a new truepath¿ device was opened.The new device functioned properly as signs of resistance have been observed.The new device, however, was not successful in crossing the lesion.Access was successfully obtained using a pedal approach after the wire was pulled through the right groin sheath.The procedure was completed with a number of balloons, drug coated balloons (dcb) and stents.There were no patient complications reported and patient left the lab in stable condition.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The control unit, motor housing, drive shaft, working length, and tip housing/tip were microscopically examined.There was contrast on the outside of the device.The tip of the device was off-set and pushed against the edge of the distal tip housing, which is not allowing the tip to be moved proximally.Functional testing was performed by turning on the device.All the led lights lit.An audible noise was heard, the device vibrated and the tip rotated.When the tip of the device was pressed against a hard surface, the two green indicator lights lit up on the control panel; however, the red alarm lamp did not light up.The control unit was switched out with a test control unit and tested with the truepath device; however, the same event occurred.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the device rotated with no audible sounds of resistance heard.The approximately 250-300mm chronic total occlusion (cto) target lesion was located in the left superficial femoral artery (sfa).Angiogram was performed in the lower extremity and revealed a long cto of the left sfa.A 2cm nub was seen at the ostium of the sfa proximal to where the cto started.Originally the lesion was attempted to be crossed with a wire and a non bsc crossing catheter but this was unsuccessful and both the wire and catheter seemed to have gone to the subintimal at the proximal cap.Then, a truepath¿ cto device has been elected to be used to attempt crossing the lesion.The device was prepped and turned on outside patient¿s body at it appeared working properly.The device was then introduced into a 0.018 non bsc catheter.Once the device was in the body and just proximal to the proximal cap, the device was then activated.As the physician was moving the device distally through the lesion, the activation light illuminated.However, the second and third light never lit up, so it was suspected that the device was not meeting any resistance inside the cto and no sound was heard.An attempt to use the device some more was made and still no signs of resistance was noted.It was then suspected that the device was not working correctly.The device was turned off and removed from the body.Once the device was out of the body, the device was again tested.This time when the device was activated, it didn't seem like it was running at full power and when the tip was place against the doctors hand, the indicator light never lit up showing resistance.At this point, the device was set aside and a new truepath¿ device was opened.The new device functioned properly as signs of resistance have been observed.The new device, however, was not successful in crossing the lesion.Access was successfully obtained using a pedal approach after the wire was pulled through the right groin sheath.The procedure was completed with a number of balloons, drug coated balloons (dcb) and stents.There were no patient complications reported and patient left the lab in stable condition.

• Brand Name: TRUEPATH¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6864485
• MDR Text Key: 86119011
• Report Number: 2134265-2017-09276
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101599
• 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,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 20432438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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
• Treatment: 0.018 QUICKCROSS
• Patient Age: 68 YR