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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
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 arteriovenous anastomosis.Two 4.0-10/4t/90 symmetry stiff shaft balloon catheters were advanced for dilatation.However, during the initial inflation at 12 atmospheres, the balloons ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 - initial reported address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device 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 for 30 seconds without issue.A vacuum was then applied.The inflation device was verified before and after use.This inflation to rate of burst pressure 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 markerbands.A visual and tactile examination found that the shaft was free from damage.No issues were noted which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
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 arteriovenous anastomosis.Two 4.0-10/4t/90 symmetry stiff shaft balloon catheters were advanced for dilatation.However, during the initial inflation at 12 atmospheres, the balloons ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries 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: 11139665
• Report Number: 2134265-2020-18564
• Device Sequence Number: 676346
• Product Code: LIT
• UDI-Device Identifier: 08714729182757
• UDI-Public: 08714729182757
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 03/09/2023
• Device Model Number: 23335
• Device Catalogue Number: 23335
• Device Lot Number: 0025327925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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 INDEF; INFLATION DEVICE: FUJI MEDICAL INDEF; INTRODUCER SHEATH: TERUMO 5FR; INTRODUCER SHEATH: TERUMO 5FR; GUIDE WIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEF; INTRODUCER SHEATH: TERUMO 5FR