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

Model Number M001BP90820B0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blade partial detachment occurred.A 2cm peripheral cutting balloon¿ was selected for use.During withdrawal, it was noted that there was "dotter of tight stenos shunt." it was also observed that surgical knives/blades came partly from balloon after withdrawing.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.An examination of the device identified that 7mm of blade and pad was partially detached on the proximal end of balloon, with 13mm of blade and pad still attached to the balloon.The total size of the blade is 2cm.The other blades were intact and fully bonded to the balloon surface.The balloon was not folded.No issues were observed with the balloon which could have contributed to the complaint incident.No issues were 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 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 further reported that dotter means "dilate vessel with balloon" and partial detachment of the blades was noted.

• 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: 6519994
• MDR Text Key: 73666243
• Report Number: 2134265-2017-03850
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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: 09/22/2018
• Device Model Number: M001BP90820B0
• Device Catalogue Number: BP908020B
• Device Lot Number: 19751213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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