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

Model Number	24630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blade was broken.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, the blade was broken and was then retrieved from the paitent's body with no harm.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that one complete blade together with approximately 12mm of its blade pad was completely detached from the balloon material.The detached blade was not returned for analysis.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon had been inflated.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified a complete break of the shaft located approximately 60mm proximal of the proximal balloon bond.The proximal hub section of the device was not returned for analysis.
Event or Problem Description
It was reported that the blade was broken.A 7.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, the blade was broken and was then retrieved from the patient's body with no harm.No patient complications were reported.

• 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: 8487325
• Report Number: 2134265-2019-03499
• Device Sequence Number: 2758680
• Product Code: PNO
• UDI-Device Identifier: 08714729813774
• UDI-Public: 08714729813774
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2020
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0022843325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR