MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	23295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
E1 - initial reporter address: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning approximately 5mm proximal of the proximal markerband and extending approximately 10mm distally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this balloon is 15 atmospheres.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.

• Brand Name: SYMMETRY
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9515013
• Report Number: 2134265-2019-16119
• Device Sequence Number: 11233633
• Product Code: LIT
• UDI-Device Identifier: 08714729181972
• UDI-Public: 08714729181972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 02/26/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023410624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 02/25/2020
• 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: GUIDE WIRE: KYOUSHANT18; GUIDE WIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR; INTRODUCER SHEATH: TERUMO 5FR