MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER 8F PRE-SHAPED 40 90CM; CATHETER, PERCUTANEOUS

Model Number	H965100440
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the tip of the subject guide catheter broke and moved to a deep cervical vein and got stuck.The physician was unable to retrieve the broken tip fragment and proceeded to use the subject catheter without tip to complete the procedure.The procedure was completed with no clinical consequences and the patient was discharged.Imaging was done approximately one month post procedure and the subject catheter tip fragment had not moved from the deep cervical vein location.No other information is available.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of undeterminable will be assigned to this complaint, as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during the procedure, the tip of the subject guide catheter broke and moved to a deep cervical vein and got stuck.The physician was unable to retrieve the broken tip fragment and proceeded to use the subject catheter without tip to complete the procedure.The procedure was completed with no clinical consequences and the patient was discharged.Imaging was done approximately one month post procedure and the subject catheter tip fragment had not moved from the deep cervical vein location.No other information is available.

• Brand Name: GUIDER 8F PRE-SHAPED 40 90CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 10946040
• Report Number: 3008853977-2020-00036
• Device Sequence Number: 19630632
• Product Code: DQY
• UDI-Device Identifier: 08714729202486
• UDI-Public: 08714729202486
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: H965100440
• Device Catalogue Number: H965100440
• Device Lot Number: 24136801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR