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	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in a moderately tortuous and mildly calcified vessel.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, upon first inflation, leakage of contrast media was observed at the tip part and during the third inflation at 10 atmospheres for 1 minute, the balloon ruptured.The device was removed and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: a sv/4.5-4/4t/90 was returned for analysis.The returned device was attached to an encore inflation device and positive pressure was applied, however the balloon did not inflate.The device was soaked in the waterbath at 37 degrees celsius to soften hardened medium that may have been present in the device.The device was removed from the bath and was attached to an encore inflation device and positive pressure was applied.The balloon was successfully inflated to its rate of burst pressure with no leaks or drops in pressure noted.The pressure was held for 30 seconds, this was recorded with a digital timer.The inflation device was verified before and after use.This inflation to rate of burst pressure of was repeated three times and with no issues or drop in pressure noted.A visual and microscopic examination of the balloon material identified no issues.A visual and microscopic examination of the markerbands identified no issues.A visual and tactile examination of the shaft and tip identified no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in a shunt in a moderately tortuous and mildly calcified vessel.A 4.5-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, upon first inflation, leakage of contrast media was observed at the tip part and during the third inflation at 10 atmospheres for 1 minute, the balloon ruptured.The device was removed and the procedure was completed.No patient complications were reported.

• 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: 9832958
• Report Number: 2134265-2020-03298
• Device Sequence Number: 16867969
• Product Code: LIT
• UDI-Device Identifier: 08714729181859
• UDI-Public: 08714729181859
• 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): 04/22/2020

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: 06/06/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023917437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1