MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP50520B0

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

It was reported that the blade lifted and became detachment.Vascular access was obtained from the same side of the lesion utilizing anterograde approach.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm.After crossing a 100cm non-bsc guide wire to the lesion, the 5.00mmx2.0cmx50cm peripheral cutting balloon¿ was delivered and dilatation was performed twice.A 7fr non-bsc sheath was used together and deflation was performed slowly at 16 atm for 5 seconds.The balloon was used without issue, however when withdrawal was attempted, small resistance was encountered.The balloon was then advanced from the distal section of the sheath and was slightly inflated and then deflated slowly.The balloon was then retracted into the sheath without issue and was removed from the patient.The device was checked outside of the patient and it was noted that one of the blade was lifted and detached.It was thought that no parts of the device fall into the patient.The procedure was completed with this device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device found that the returned balloon had evidence of being inflated and blood was identified within the balloon and inflation lumen.Blood within the balloon or inflation lumen is evidence of a device leak.A microscopic examination identified that approximately 6 mm of the proximal end of a blade and pad had detached from the balloon.A microscopic examination observed no damage to the additional blades.These blades were present and fully bonded to the balloon surface.No damage was noted to the tip of the device.No kinks or damage were noticed along the shaft of the device.During analysis, the device was connected to an encore inflation unit and a vacuum was pulled for balloon preparation prior to advancement through the recommended size introducer sheath as identified on the product label.The device was inserted over a 0.018 inch guidewire and through a 7fr introducer sheath without issue.Positive pressure was applied when liquid was observed to be leaking from a pinhole in the balloon material at 3 mm distal to the distal of the proximal markerband.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 the blade lifted and became detachment.Vascular access was obtained from the same side of the lesion utilizing anterograde approach.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm.After crossing a 100cm non-bsc guide wire to the lesion, the 5.00mmx2.0cmx50cm peripheral cutting balloon was delivered and dilatation was performed twice.A 7fr non-bsc sheath was used together and deflation was performed slowly at 16 atm for 5 seconds.The balloon was used without issue, however when withdrawal was attempted, small resistance was encountered.The balloon was then advanced from the distal section of the sheath and was slightly inflated and then deflated slowly.The balloon was then retracted into the sheath without issue and was removed from the patient.The device was checked outside of the patient and it was noted that one of the blade was lifted and detached.It was thought that no parts of the device fall into the patient.The procedure was completed with this device.No patient complications were reported and the patient's condition was good.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 4837791
• MDR Text Key: 5938011
• Report Number: 2134265-2015-03572
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: M001BP50520B0
• Device Catalogue Number: BP505020B
• Device Lot Number: 0017659949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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
• Treatment: GUIDEWIRE: GT016 100CM TERUMO; BALLOON CATHETER: PCB2CM OTW 5.0-20/4.2/50