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

Model Number 23295

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2020

Event Type  malfunction  

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 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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9995825
• MDR Text Key: 189031056
• Report Number: 2134265-2020-04768
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729181958
• UDI-Public: 08714729181958
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1