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

Model Number	23295
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: a sv/6.0-2/4t/90 was returned for analysis.The detached distal end of the device was not returned for analysis.The distal section of the device, including the balloon, detached from the device 870mm distal from the strain relief.A visual and microscopic examination identified no other issues no other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 02-apr 2020.It was reported that balloon catheter was missing.A 6.0-2/4t/90 symmetry balloon catheter was found missing when out of the package during preparation.However, returned device analysis revealed shaft detached.

• 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: 9995825
• Report Number: 2134265-2020-04768
• Device Sequence Number: 3699867
• Product Code: LIT
• UDI-Device Identifier: 08714729181958
• UDI-Public: 08714729181958
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: 04/23/2022
• Device Model Number: 23295
• Device Catalogue Number: 23295
• Device Lot Number: 0023689897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1