MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM4015140F0

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a blade was missing.The 4cm in length target lesion was located in a tortuous vein near the shunt anastomosis on the upper limb.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During procedure, the device was inflated four times at 6atm respectively for 60 seconds.After the procedure, the device was removed from the sheath; however it was noted that a part of the blade was missing.Ct scan was performed and confirmed that the blade did not remain inside patient¿s body.No patient complications were reported.

Manufacturer Narrative

The device was returned for analysis.An examination of the device identified approximately 3.2mm of one of the blades was completely detached from the balloon material; however the pad was still attached to the balloon.This damage can potentially be the result of the resistance that was encountered as the balloon catheter was being removed.All other blades were fully bonded to the balloon material and no issues were identified that could have contributed to the complaint incident.A visual examination of the dissected balloon protector determined that the detached piece of blade was not inside the balloon protector cap.The balloon was unfolded which indicated it have been subjected to positive pressure.The balloon was inflated to its rated burst pressure without any issues noted.A visual and tactile inspection identified multiple kinks along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.No damage was observed to the tip or markerbands of the device which could potentially have contributed to this complaint incident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the dfu states: ¿¿use only a 6f (2.00 mm) or larger introducer sheath.Do not advance the guidewire or the peripheral cutting balloon device if the sheath is kinked, buckled or offers resistance.A tight sheath can press the balloon material against an atherotome with sufficient force to puncture the balloon.If resistance is encountered when removing the catheter through an introducer sheath or a guidewire through the catheter, stop and remove them as a complete unit to prevent damage to the guidewire, catheter, introducer sheath, or vessel." (b)(4).

Event Description

It was reported that a blade was missing.The 4cm in length target lesion was located in a tortuous vein near the shunt anastomosis on the upper limb.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During procedure, the device was inflated four times at 6atm respectively for 60 seconds.After the procedure, the device was removed from the sheath; however it was noted that a part of the blade was missing.Ct scan was performed and confirmed that the blade did not remain inside patient¿s body.No patient complications were reported.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6584527
• MDR Text Key: 75777760
• Report Number: 2134265-2017-04984
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 18710183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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