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

Model Number M001BP35620B0

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the blade was about to detach.The vascular access was obtained via the left femoral artery with retrograde approach.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery (eia).A 6.00mmx2.0cmx135cm peripheral cutting balloon was used to treat the target lesion.Dilation was performed in two locations at 6atm for 30 seconds.When the balloon catheter was started to be withdrawn in the sheath, a small resistance was encountered.The balloon catheter was carefully removed from the patient and it was noted that the blade was about to detach after checking it outside the patient.The procedure was completed with a different device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Solidified contrast media was identified within the balloon.A microscopic examination identified that approximately 6mm of the proximal end of a blade and blade pad were lifted from the balloon; however, no section was detached.Approximately 4mm of the proximal end of the blade pad was still intact.A microscopic examination observed no damage to the additional blades.These blades were present and fully bonded to the balloon surface.No damage was noted to the tip or balloon of the device.During analysis, the device was attached to an encore inflation unit.The balloon was unable to be completely deflated prior to insertion through the recommended size 7fr sheath as identified on the product label due to the solidified contrast media within the balloon.The device was soaked in a water bath at 37 degrees to help soften the solidified contrast media.After soaking, a vacuum was pulled for balloon preparation and the catheter was advanced through the sheath and positive pressure was applied.The balloon was able to be inflated to its rated burst pressure of 10 atmospheres and maintained pressure with no leaks noted.The encore inflation unit was verified before and after use using a calibrated pressure gauge.The device was deflated and removed through the sheath without issue.No kinks or damage were noticed along the shaft of the device.It is possible that resistance between the device and sheath could potentially have resulted in part of the blade getting caught on the introducer sheath and lifting from the balloon.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 the blade was about to detach.The vascular access was obtained via the left femoral artery with retrograde approach.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery (eia).A 6.00mmx2.0cmx135cm peripheral cutting balloon¿ was used to treat the target lesion.Dilation was performed in two locations at 6atm for 30 seconds.When the balloon catheter was started to be withdrawn in the sheath, a small resistance was encountered.The balloon catheter was carefully removed from the patient and it was noted that the blade was about to detach after checking it outside the patient.The procedure was completed with a different device.No patient complications were reported and the patient's condition was good.

• 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: 5021762
• MDR Text Key: 23720328
• Report Number: 2134265-2015-05949
• 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: Followup
• Report Date: 07/23/2015

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: 12/10/2016
• Device Model Number: M001BP35620B0
• Device Catalogue Number: BP1356020B
• Device Lot Number: 0017533891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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