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

Model Number	H74939401153500
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.The returned product consisted of a wolverine balloon catheter.A visual examination identified that the balloon of the device was tightly wrapped and had not been subjected to positive pressure.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.During the product analysis the investigator was unable to load the device on to a boston scientific 0.014" guidewire due to damage to the guidewire lumen.The guidewire used by the customer was not returned for analysis.A microscopic examination identified that the inner guidewire lumen of the shaft was stretched and bunched approximately 20mm proximal of the proximal balloon bond.A pinhole on the outer shaft was also identified located approximately 21mm proximal of the proximal balloon bond.A visual and tactile examination identified multiple kinks along the length of the hypotube of the device.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 or Problem Description
Reportable based on analysis completed 16 aug 2018.It was reported that a guidewire was unable to pass through the guidewire lumen.They used another of the same device to complete the procedure.It never went into the patient's body.However returned device analysis revealed there was a hole in the outer shaft of the device.

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7856160
• Report Number: 2134265-2018-07414
• Device Sequence Number: 1271871
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P950020/S072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: H74939401153500
• Device Catalogue Number: 39401-15350
• Device Lot Number: 0022131642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1