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

Model Number	23335
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.5-10/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres for 30 seconds, contrast media was found to be leaking and the pressure could not be maintained and it immediately dropped below 10 atmospheres.Pressurization and depressurization were repeatedly performed up to 14atm several times, and it was found out that the balloon ruptured.After that, 3.5x100mm symmetry balloon catheter was unpacked, then the procedure was continued and it was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic examination found no issue with the tip of the device that could have potentially contributed to the complaint incident.A visual and microscopic examination found no issue with the markerbands that could have potentially contributed to the complaint incident.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.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal end of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found no kinks or other damage along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 3.5-10/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres for 30 seconds, contrast media was found to be leaking and the pressure could not be maintained and it immediately dropped below 10 atmospheres.Pressurization and depressurization were repeatedly performed up to 14atm several times, and it was found out that the balloon ruptured.After that, 3.5x100mm symmetry balloon catheter was unpacked, then the procedure was continued and it was completed successfully.No patient complications were reported.

• Brand Name: SYMMETRY STIFF SHAFT
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8544177
• Report Number: 2134265-2019-04224
• Device Sequence Number: 13885893
• Product Code: LIT
• UDI-Device Identifier: 08714729182665
• UDI-Public: 08714729182665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• 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): 05/27/2019

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 Expiration Date: 07/08/2021
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0022346826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/27/2019
• 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: GUIDE WIRE: KYOUSHANT 18; GUIDE WIRE: KYOUSHANT 18; INFLATION DEVICE: KANEKA INDEFLATOR; INFLATION DEVICE: KANEKA INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR 4CM; INTRODUCER SHEATH: TERUMO 5FR 4CM; GUIDE WIRE: KYOUSHANT 18; INFLATION DEVICE: KANEKA INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR 4CM