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

Model Number M001BP50620B0

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that sheath got broken.A 6.00mm / 50cm 2cm peripheral cutting balloon¿ was selected for use.Upon withdrawal, the sheath was simply pulled out from the patent's body; however it was noted to be broken.The procedure was completed with this device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The balloon was returned partially inflated with inflation medium within the balloon material.A visual and microscopic examination was performed on the balloon material.No damage was noted on the balloon material.The 6fr introducer sheath used during the procedure was returned for analysis.The entire length of the returned sheath was observed to be torn.A 6fr boston scientific sheath was used to complete the analysis as the returned sheath was torn.On analysis, a vacuum was applied and the balloon fully deflated.The device was successfully advanced through and withdrawn from the 6fr boston scientific sheath without any resistance or issues observed.A visual and microscopic examination on the blade was performed, it was noted that approximately 2mm of one of the blades was lifted from the balloon material.The pad was intact.This damage can potentially be a result of the resistance encountered during the withdrawal of the device.The remainder of the blade was undamaged and fully attached to the balloon material.All other blades were present and fully bonded to the balloon material.No issues were noted with the blades or pads that have contributed to the complaint incident.A visual and tactile examination on the shaft was performed, no kinks or damage along the shaft of the device were found.A visual and tactile examination on the markerband/tip was performed.No issues with the markerband or tip that could have contributed to the complaint incident were identified.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The dfu small peripheral cutting balloon cautions state: "if resistance is encountered when removing the catheter through an introducer sheath or guidewire through the catheter, stop and remove them as a complete unit to prevent damage to the guidewire, catheter, introducer sheath or vessel." (b)(4).

Event Description

It was reported that sheath got broken.A 6.00mm/50cm 2cm peripheral cutting balloon was selected for use.Upon withdrawal, the sheath was simply pulled out from the patent's body; however it was noted to be broken.The procedure was completed with this device.No patient complications were reported and patient's status was stable.

• 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: 7704216
• MDR Text Key: 114550737
• Report Number: 2134265-2018-06475
• 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,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2020
• Device Model Number: M001BP50620B0
• Device Catalogue Number: BP506020B
• Device Lot Number: 0021849462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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