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

Model Number	23295
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment occurred.A 4.5-4/4t/90 symmetry balloon catheter was selected for dilation.However, the guidewire was stuck inside the shaft around the balloon part and the catheter could not be placed on the wire.Another 4.0-4/4t/90 symmetry balloon catheter was selected but the balloon was torn during preparation.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that catheter entrapment occurred.A 4.5-4/4t/90 symmetry balloon catheter was selected for dilation.However, the guidewire was stuck inside the shaft around the balloon part and the catheter could not be placed on the wire.Another 4.0-4/4t/90 symmetry balloon catheter was selected but the balloon was torn during preparation.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(e1) initial reporter city: (b)(6).Device evaluated by mfr.: symmetry device - sv/4,5-4/4t/90 was returned for analysis.This symmetry device is recommended for use with a 0.018" (0.457mm) guidewire.The customer's guidewire was not returned for analysis.During product analysis the investigator could not load the device on to a guidewire due to shaft damage.A visual and microscopic examination found the shaft of the device to have severe crush damage between the proximal balloon bond and the proximal markerband.This type of damage is consistent with excessive force being applied to the delivery system.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 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.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 other issues were identified during the product analysis.

• 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: 10390252
• Report Number: 2134265-2020-10037
• Device Sequence Number: 2942267
• 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): 09/14/2020

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: 0023917436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1