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

Model Number H749RB4325100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6) or older.(b)(4).

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.A 10/3.25 flextome¿ cutting balloon¿ was selected to treat the target lesion.The physician used 1.5mm to 2.00mm rotaburr to perform ablation and a 30/3.0 emerge to perform pre dilatation.As indentation could not be achieved, the physician used the 10/3.25 flextome¿ cutting balloon¿ to perform pre dilatation.The balloon was inflated at 10 atm 20 seconds.At the third inflation, it was noted that the contrast agent was leaking.The balloon had to be removed.The procedure was completed with a 16/3.0 promus premier.The balloon rupture could not be observed visually.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned unit was attached to an inflation device.Positive pressure was applied when liquid was observed to be leaking from a longitudinal tear in the balloon body which started at the proximal end of the proximal markerband and extended to the distal end of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found that the hypotube was kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted during product analysis.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 balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.A 10/3.25 flextome¿ cutting balloon¿ was selected to treat the target lesion.The physician used 1.5mm to 2.00mm rotaburr to perform ablation and a 30/3.0 emerge to perform pre dilatation.As indentation could not be achieved, the physician used the 10/3.25 flextome¿ cutting balloon¿ to perform pre dilatation.The balloon was inflated at 10 atm 20 seconds.At the third inflation, it was noted that the contrast agent was leaking.The balloon had to be removed.The procedure was completed with a 16/3.0 promus premier.The balloon rupture could not be observed visually.No patient complications were reported and the patient's status was good.

• Brand Name: FLEXTOME¿ CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 5305598
• MDR Text Key: 33721451
• Report Number: 2134265-2015-08709
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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: 05/18/2018
• Device Model Number: H749RB4325100
• Device Catalogue Number: RB432510
• Device Lot Number: 18004535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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: BALLOON CATHETER:EMERGE/30/3.0/BOSTON