MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM2015140F0

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.Vascular access was obtained via left inguinal region using a 6.5 non-bsc sheath.The 90% stenosed target lesion was located in the mildly calcified and mildly tortuous left superficial femoral artery (sfa).After a 0.014 non-bsc guide wire crossed the lesion, a 2.00mm x 1.5cm x 140cm small peripheral cutting balloon¿ monorail was advanced and dilated the lesion well.When the device was retracted into the sheath, strong resistance was encountered.The device including the balloon was retracted into the sheath and no deformation was noted.The device together with the sheath were removed from the patient.The physician flushed the device via the port side of the sheath to remove the device from the sheath; however, resistance was encountered.The device was pulled carefully and moved a little but the monorail part got stretched and the shaft was detached inside the sheath.There were no fragments and blades remained inside the patient.The procedure was completed with a 4-20 non-bsc balloon catheter.No patient complications were reported and the patient¿s status was good.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.During device analysis, it was revealed that the outer shaft profile was stretched distal to the guidewire exit port.A visual and tactile examination found that the midshaft was broken distal to the midshaft/hypotube bond.The midshaft was severely stretched, kinked and twisted along its length.The hypotube was also kinked along its length.A visual examination of the balloon/blade identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak consistent with the midshaft detach.The balloon protector was not received at the cis for analysis.A vacuum was unable to be pulled for balloon preparation due to the break in the midshaft.As a result of this, the device was unable to be inserted through the recommended size 6 fr introducer sheath as identified on the product label.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 a shaft break occurred.Vascular access was obtained via left inguinal region using a 6.5 non-bsc sheath.The 90% stenosed target lesion was located in the mildly calcified and mildly tortuous left superficial femoral artery (sfa).After a 0.014 non-bsc guide wire crossed the lesion, a 2.00mm x 1.5cm x 140cm small peripheral cutting balloon¿ monorail was advanced and dilated the lesion well.When the device was retracted into the sheath, strong resistance was encountered.The device including the balloon was retracted into the sheath and no deformation was noted.The device together with the sheath were removed from the patient.The physician flushed the device via the port side of the sheath to remove the device from the sheath; however, resistance was encountered.The device was pulled carefully and moved a little but the monorail part got stretched and the shaft was detached inside the sheath.There were no fragments and blades remained inside the patient.The procedure was completed with a 4-20 non-bsc balloon catheter.No patient complications were reported and the patient¿s status was good.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4912269
• MDR Text Key: 6836885
• Report Number: 2134265-2015-04463
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: M001BPM2015140F0
• Device Catalogue Number: BPM2015140F
• Device Lot Number: 0015752531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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: STENT: SMART