MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number H74939401104000

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the wolverine device was received and analyzed.One of the blades and pads was returned completely detached for analysis.A thorough visual and microscopic examination was performed on the blades of the returned device.It was noted that two entire blades and pads were completely detached from the balloon material.However, only one detached blade and pad were returned for analysis.The midpoint of this detached blade was noted to be damaged which may have occurred when the blade was pulled from the balloon material.The glue bonds were intact at each end of the blade.The detached blade and pad were intact and still bonded to each other, no issues were noted with either the blade or pad that could have contributed to the detachment from the balloon material.The other two blades and pads were intact and still fully bonded to the balloon material.The second detached blade and pad were not returned for analysis.A visual and tactile examination identified multiple kinks along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that may have contributed to the complaint incident.A visual and microscopic examination was performed on the returned balloon material.The balloon material was returned unfolded and solidified inflation medium was noted within the balloon material which indicates the balloon had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified inflation medium within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified inflation medium before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when liquid was seen escaping from a balloon pinhole leak approximately 4mm distal to the distal edge of the proximal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the tip or markerbands of the device.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 analysis completed (b)(6) 2018.It was reported that blade detachment occurred post procedure during manipulation of the device.The chronic total occluded target lesion was moderately tortuous, calcified and >20 mm in length.A 10mm x 4.00mm wolverine¿ coronary cutting balloon® monorail® was inflated three times between nominal and rated pressure for 10-15 seconds each.The cutting balloon performed well in the case.The blades were completely secure to the balloon immediately post procedure.There were no patient compilations.After the procedure, a fellow was playing with the device on the back table when one blade fell off and another blade partially detached.However, returned device analysis revealed a pinhole in the balloon material.

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• 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: 7359117
• MDR Text Key: 103283591
• Report Number: 2134265-2018-01972
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020/S072
• 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
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: H74939401104000
• Device Catalogue Number: 39401-10400
• Device Lot Number: 0021395001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1