MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY 40; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 23295

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported catheter entrapment occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified forearm vein.A sv/5.0-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, the device became stuck with the.018 non- boston scientific guidewire.The device was removed from the patient and the procedure was completed with another of same device.No patient complications nor injuries were reported.The patient condition was good.

Event Description

It was reported catheter entrapment occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified forearm vein.A sv/5.0-4/4t/40 symmetry 40 balloon catheter was advanced for dilatation.However, the device became stuck with the.018 non- boston scientific guidewire.The device was removed from the patient and the procedure was completed with another of same device.No patient complications nor injuries were reported.The patient condition was good.

Manufacturer Narrative

(e1) initial reporter city: (b)(6).Corrections: (d4) lot number: updated from 0027462340 to 0027414239.(d4) expiration date: updated from 06/08/2024 to 05/31/2024.(h4) device manufacture date: updated from 06/09/2021 to 06/01/2021.Device evaluated by mfr.: a symmetry sv/5.0-4/4t/40 was returned for analysis.The customers guidewire was returned for analysis and was kinked, and the coating was damaged.The investigator was unable to load the device on to the customers guidewire due to the wire being kinked and damage to its polymer coating.During product analysis the investigator successfully loaded the device on to a boston scientific 0.018" zipwire without issue.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination identified no issues.A visual and tactile examination identified no issues with tip of this device.No issues were identified during the product analysis.

• Brand Name: SYMMETRY 40
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12439590
• MDR Text Key: 270318462
• Report Number: 2134265-2021-11000
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0027414239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: RADIFOCUS .018; GUIDEWIRE: RADIFOCUS .018; GUIDEWIRE: RADIFOCUS .018