MAUDE Adverse Event Report: GREATBATCH MEDICAL 9 FR BOSTON SCIENTIFIC CHANNEL STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	10795-003
Medical Device Problem Codes	Material Frayed (1262); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the steering fiber was pulled out of the distal tip of the sheath.The sheath was removed without harm to the patient.The report was communicated on (b)(6) 2020.

• Brand Name: 9 FR BOSTON SCIENTIFIC CHANNEL STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire ln; minneapolis, mn
• MDR Report Key: 10407364
• Report Number: 2183787-2020-00080
• Device Sequence Number: 11494369
• Product Code: DYB
• UDI-Device Identifier: 08714729862420
• UDI-Public: (01)08714729862420(17)210124(10)GB5218235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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: 01/24/2021
• Device Model Number: 10795-003
• Device Catalogue Number: N/A
• Device Lot Number: GB5218235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1