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	03/17/2020
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 the moderately tortuous and mildly calcified vessel.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, on initial inflation at 12 atmospheres for less than 30 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.A 3.5-10/4t/90 symmetry stiff shaft balloon catheter was advanced for dilatation.However, on initial inflation at 12 atmospheres for less than 30 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).(e1) initial reporter city: (b)(6).Device evaluated by mfr.: symmetry stiff shaft balloon catheter was returned for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure without issue.A vacuum was then applied.The inflation device was verified, before and after use with a calibrated pressure gauge.This inflation was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination found no damage or issues with shaft of the device.No issues were identified during the product analysis.

• 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: 9909920
• Report Number: 2134265-2020-04218
• Device Sequence Number: 3354322
• 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): 05/01/2020

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: 10/21/2022
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0024637622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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: GUIDEWIRE: GT WIRE; GUIDEWIRE: GT WIRE; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 4FR; INTRODUCER SHEATH: TERUMO 4FR; GUIDEWIRE: GT WIRE; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 4FR