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

Model Number M001PCB6020900

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was not returned for 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 a detach balloon blade occurred.The target lesion was located in the left pulmonary artery.A 6mm x 2cm peripheral cutting balloon® was selected for use.During procedure, the balloon was removed from the patient's body when it was noted that the one of the balloon blades came off and ended up in the left pulmonary artery.The detached blade was snared without causing any harm to the patient.The procedure was completed with this device.No further patient complications were noted and the patient's status was okay.

• 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: 6814738
• MDR Text Key: 83432994
• Report Number: 2134265-2017-08368
• 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
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2019
• Device Model Number: M001PCB6020900
• Device Catalogue Number: PCB602090
• Device Lot Number: 20568528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• 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
• Patient Outcome(s): Required Intervention