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

Model Number M001PCB8020500

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a blade was broken.The target lesion was located in a right upper extremity fistula.An 8.00mm/2.0cm/50cm peripheral cutting balloon was used to dilate the lesion.When the balloon catheter was pulled out of the patient, it was noted that the blade was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was fine.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.An examination of the device identified that a blade and pad had lifted off the balloon.The blade was still attached to the balloon.Eight mm of the blade was attached from its distal end.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.No issues were noted with its shaft polymer extrusion profile.A visual and tactile examination found no kinks or damage along 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 reported that a blade was broken.The target lesion was located in a right upper extremity fistula.An 8.00mm/2.0cm/50cm peripheral cutting balloon® was used to dilate the lesion.When the balloon catheter was pulled out of the patient, it was noted that the blade was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was fine.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5591440
• MDR Text Key: 43168703
• Report Number: 2134265-2016-03460
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

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: 07/23/2017
• Device Model Number: M001PCB8020500
• Device Catalogue Number: PCB802050
• Device Lot Number: 18228606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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
• Patient Age: 65 YR