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

Model Number M001BP90620B0

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

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 peeled off.A 90% stenosed target lesion located at the mildly tortuous and mildly calcified right femoral artery.A 6.00 mm x 2.0 cm x 90 cm otw 2 cm peripheral cutting balloon¿ was used to pre dilate the lesion.The lesion was dilated with this device successfully.Inflation was done 4 times at 60 seconds each.However; during retrieval, when the non bsc introducer was pulled then inserted, resistance was felt but was able to retrieve the device.When the balloon was checked, it was noted that a part of the blade was peeled off.No part of the device remained inside the patient¿s body.The procedure was not completed due to another reason.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination found no damage to the shaft of the device.An examination of the blade identified that 4mm of blade was lifted on the proximal end of balloon, with 16mm of blade and 20mm of pad still attached to the balloon.The total size of the blade is 2cm.The balloon was not folded and saline solution was visible within the balloon.The returned device was attached to an encore inflation unit.Positive pressure was applied and a balloon pinhole leak was observed 4.5mm 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.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 peeled off.A 90% stenosed target lesion located at the mildly tortuous and mildly calcified right femoral artery.A 6.00mmx2.0cmx90cm otw 2cm peripheral cutting balloon¿ was used to pre dilate the lesion.The lesion was dilated with this device successfully.Inflation was done 4 times at 60 seconds each.However; during retrieval, when the non bsc introducer was pulled then inserted, resistance was felt but was able to retrieve the device.When the balloon was checked, it was noted that a part of the blade was peeled off.No part of the device remained inside the patient¿s body.The procedure was not completed due to another reason.No patient complications 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: 6516689
• MDR Text Key: 73536191
• Report Number: 2134265-2017-03707
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2019
• Device Model Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Device Lot Number: 0020186913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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: GUIDEWIRE: JUPITERFC; INTRODUCER SHEATH: TERUMO DESTINATION