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

Model Number M001BP90620B0

Device Problems Deflation Problem (1149); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the sheath became torn.The target lesion was located in the moderately tortuous shunt of the limb.A 2cm peripheral cutting balloon¿ was selected for use.Upon removal of the cutting balloon, it was noted that the sheath was torn vertically.Deflation was then performed slowly.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned device was received together with customers introducer sheath.A visual examination identified that the shaft of the customers introducer sheath was split along its entire length.This type of damage is consistent with attempting to withdraw the device before the balloon was completely deflated.An examination of the returned device identified that the balloon had been inflated and was not refolded.The balloon and blades of the device were visually and microscopically examined and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.The investigator inflated the balloon to its rate of burst pressure 10 atmospheres to observe inflation and then applied a vacuum to observe deflation of the balloon.Both inflation and deflation were hindered due to a severe kink on the shaft of the device.No other issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination found that the shaft was severely kinked at approximately 23mm proximal of the proximal balloon bond.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted which may have potentially contributed to the complaint incident.Product analysis identified no evidence that the sheath of the pcb device was ripped/ split.A visual and microscopic examination found no issue with the markerbands.No issues were noted with the tip section of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the sheath became torn.The target lesion was located in the moderately tortuous shunt of the limb.A 2cm peripheral cutting balloon was selected for use.Upon removal of the cutting balloon, it was noted that the sheath was torn vertically.Deflation was then performed slowly.The procedure was not completed due to this event.No patient complications were reported and the 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: 7396204
• MDR Text Key: 104571546
• Report Number: 2134265-2018-02574
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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: 09/06/2019
• Device Model Number: M001BP90620B0
• Device Catalogue Number: BP906020B
• Device Lot Number: 0021098074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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