MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY OFFROAD¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939202070540

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

It was reported that a during a percutaneous transluminal angioplasty , a shaft break occurred.The stenotic chronic total occlusion (cto) target lesion was located in the heavily calcified superficial femoral artery (sfa).Following advancement of the offroad¿ re-entry system, the offroad re-entry balloon was inflated to nominal pressure (2atm) in a sub-intimal space and the lancet moved forward to get re-entry.No entry possible.Then when trying to pull the needle back a few cm resistance was felt.When trying to re-position balloon to do a second attempt some force was used on the balloon.Due to the fact that the vessel was stenotic and very calcified.The lancet very hard to move forward, and when trying to retract it, the lancet cracked.To make sure nothing was left inside the patient the balloon and lancet was removed completely from patient.Upon removal it was noted that the lancet was broken.No further re-entry attempt was performed and procedure was concluded.No patient complications were reported and the patient¿s status is stable.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes device evaluated by manufacturer - a visual examination of the returned balloon catheter identified no kinks or damage.A 0.035inch size wire was inserted through the balloon catheter with no resistance noted.An examination of the balloon section of the device identified no issues.An examination of the micro catheter identified that a break had occurred in the shaft.The break was located at 7.2cm distal to strain relief.As a result of the break the inner sleeve was exposed.The micro catheter was kinked at various locations along its length.It is noted that the break and the kinks are all consistent with excessive force having been applied to the shaft.No issues were noted with the lancet tip.No issues were noted with the profile of the micro catheter tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a during a percutaneous transluminal angioplasty , a shaft break occurred.The stenonic chronic total occlusion (cto) target lesion was located in the heavily calcified superficial femoral artery (sfa).Following advancement of the offroad¿ re-entry system, the offroad re-entry balloon was inflated to nominal pressure (2atm) in a sub-intimal space and the lancet moved forward to get re-entry.No entry possible.Then when trying to pull the needle back a few cm resistance was felt.When trying to re-position balloon to do a second attempt some force was used on the balloon.Due to the fact that the vessel was stenotic and very calcified.The lancet very hard to move forward, and when trying to retract it, the lancet cracked.To make sure nothing was left inside the patient the balloon and lancet was removed completely from patient.Upon removal it was noted that the lancet was broken.No further re-entry attempt was performed and procedure was concluded.No patient complications were reported and the patient's status is stable.

• Brand Name: OFFROAD¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4877834
• MDR Text Key: 19605497
• Report Number: 2134265-2015-04069
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939202070540
• Device Catalogue Number: 39202-07054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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