MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number	24630
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade lift occurred.The target lesion area was located in the fistula.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure it was noted that the blade lifted after it was pulled out from the patient's fistula.The device was completely pulled out using a non-bsc sheath.The procedure was completed with the original device used.No patient complications were reported.
Event or Problem Description
It was reported that the blade lift occurred.The target lesion area was located in the fistula.A 8.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure it was noted that the blade lifted after it was pulled out from the patient's fistula.The device was completely pulled out using a non-bsc sheath.The procedure was completed with the original device used.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.One of the cutting blades was separated from the balloon material.Device analysis noted that approximately 11mm of one of the cutting blades was detached from the balloon on the proximal end, it was noted that the pad was fully intact.Note: when the device was received the lifted blade was still attached as described in the event description, however the returned device was received wrapped up in a mop cap.During the removal of the mop hat from the balloon the lifted blade became detached from the device.An examination of the balloon material and blades identified no other issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9292602
• Report Number: 2134265-2019-13374
• Device Sequence Number: 2448179
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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 Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0024128506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR SHEATH; 7FR SHEATH