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

Model Number M001BPM4015140F0

Device Problems Material Rupture (1546); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual examination on the balloon identified no issues with the balloon.The balloon was not folded.There was no damage to the blades.A visual examination on the catheter shaft identified a break in the inner shaft of the balloon approximately 1mm proximal to the distal end of the tip.As a result of the break in the inner shaft, liquid leaked out through the tip during attempts to inflate the balloon.The break is consistent with excessive tensile force having been applied to the shaft during the removal of the balloon protector.The balloon protector was not received for analysis.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 handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 15-mar-2018.It was reported that difficulty in withdrawing the catheter from the protective hoop and balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery (sfa).A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, when taking out the balloon catheter from the protective hoop, it was noted that slight resistance was felt.Furthermore, the balloon catheter was advanced to the lesion; however, it was noted that at first inflation, balloon ruptured at "4atm".The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a break in the inner shaft approximately 1mm proximal to the distal end of the tip.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 7407266
• MDR Text Key: 104833399
• Report Number: 2134265-2018-02658
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2018

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: 11/06/2020
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 21351397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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