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

Model Number M001PCB6020500

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).

Event Description

Same case as mdr id: 2134265-2017-00803.It was reported that the balloon blades were lifted and sheared the sheath.A 2.00mm x 6cm flextome® cutting balloon® and a 6fr x 11cm super sheath were selected for use.During the procedure, it was noted that the balloon blades were lifted and sheared the sheath during extraction.The sheath was removed intact with no parts noted to be missing.It was further observed that the balloon had tears and was not completely rewrapped upon inspection outside patient's body.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.An examination of the device identified that 1cm of blade and pad was lifted on the proximal end of balloon, with 1cm of blade and pad was still attached to the balloon.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device most likely due to the operational context of the procedure.The total size of the blade is 2cm.The balloon was not refolded and blood was observed on the outside and on the inside of the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied and a balloon pinhole leak was observed 9mm proximal to the proximal edge of the distal markerband.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found multiple kinks on the shaft of the device.This type of damage is consistent with excessive force being applied to the delivery system during device use.The sheath used was not returned for analysis.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

Same case as mdr id: 2134265-2017-00803.It was reported that the balloon blades were lifted and sheared the sheath.A 2.00mm x 6cm flextome® cutting balloon® and a 6fr x 11cm super sheath were selected for use.During the procedure, it was noted that the balloon blades were lifted and sheared the sheath during extraction.The sheath was removed intact with no parts noted to be missing.It was further observed that the balloon had tears and was not completely rewrapped upon inspection outside patient's body.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: 6312351
• MDR Text Key: 66862992
• Report Number: 2134265-2017-00597
• 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,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001PCB6020500
• Device Catalogue Number: PCB602050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• 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