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 Pain (1994)

Event Date 12/25/2015

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) or older. (b)(4).

Event Description

It was reported that the patient felt pain and the blade was lifted.The lesion was located in the moderately tortuous and moderately calcified upper arm shunt.A 6.00mm x 2.0cm x 90cm peripheral cutting balloon¿ was selected for use.During the procedure, the balloon was inflated but the position of the balloon moved a little and the patient felt pain.It was also noted that the blade was lifted.The device was successfully removed.The procedure was not completed and no further patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that slight bleeding was found.The target lesion was located near the axillary vein.It was punctured with the sheath(7fr), a guidewire and the pcb balloon were passed the lesion, subsequently a balloon was inflated.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that approximately 6mm of the proximal section of the blade was lifted and detached.The pads were intact.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.The remaining blades were fully bonded to the balloon and no damage was noted to the other blades.No issues were noted with its profile.No other issues were identified during the product analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.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 slight bleeding was found.The target lesion was located near the axillary vein.It was punctured with the sheath (7fr), a guidewire and the pcb balloon were passed the lesion, subsequently a balloon was inflated.

• 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: 5382439
• MDR Text Key: 36467923
• Report Number: 2134265-2016-00050
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other