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

Model Number M001BP50520B0

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the blade was lifted.The target lesion was located in a moderately tortuous forearm shunt.A 5.00mm / 2.0cm / 50cm peripheral cutting balloon¿ was selected for use.During the procedure, when the device was pulled out from a 6f non bsc sheath, the blade was noted to be lifted.The procedure was completed with this device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the device was returned for analysis.An examination of the blade was performed and identified a 5 mm of blade was lifted at the proximal end of balloon, with 15 mm of the blade still attached to the balloon.The total size of the blade is 2 cm.No damage was observed with the other blades on the device.The balloon was not refolded and contrast media was observed within the balloon indicating it had been subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied and a balloon pinhole leak was observed 7 mm distal to the distal edge of the proximal markerband.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no damage to the shaft of the device.The sheath used was not returned for analysis.No other issues were identified during the product analysis.No other issues were identified during the product analysis.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 was lifted.The target lesion was located in a moderately tortuous forearm shunt.A 5.00 mm / 2.0 cm / 50 cm peripheral cutting balloon¿ was selected for use.During the procedure, when the device was pulled out from a 6f non bsc sheath, the blade was noted to be lifted.The procedure was completed with this device.No patient complications were reported.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 6497003
• MDR Text Key: 72988688
• Report Number: 2134265-2017-03492
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: M001BP50520B0
• Device Catalogue Number: BP505020B
• Device Lot Number: 0019436452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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