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

Model Number M001BP90520B0

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that one-third of the balloon blade was lifted.The 80% stenosed target lesion was located in the moderately tortuous shunt limb.A 5.00mm / 2.0cm / 90cm otw 2cm peripheral cutting balloon¿ was selected for use.During procedure, it was noted that one-third of the blade was peeled off.The procedure was not completed due to this event.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.Device analysis revealed no tears or holes were identified in the balloon.The balloon was not refolded.An examination of the balloon found that 4 mm of the proximal end of the blade was lifted on the balloon.The main section of pad was still attached to the balloon.The remaining blades were inspected and no issues were noted.No issues were identified with the tip.A visual and tactile examination identified no damage along the entire length of the shaft.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 reported that one-third of the balloon blade was lifted.The 80% stenosed target lesion was located in the moderately tortuous shunt limb.A 5.00 mm / 2.0 cm / 90 cm otw 2 cm peripheral cutting balloon¿ was selected for use.During procedure, it was noted that one-third of the blade was peeled off.The procedure was not completed due to this event.No patient complications were 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: 6304341
• MDR Text Key: 66613637
• Report Number: 2134265-2017-00639
• 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
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001BP90520B0
• Device Catalogue Number: BP905020B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• 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
• Treatment: INTRODUCER SHEATH - 6F