MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/40XF/8FR/90CM; CATHETER, PERCUTANEOUS

Model Number	H965100440
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the guide catheter shaft was compressed and severely kinked at its proximal section.The guide catheter proximal tubing was ripped due to the severity of the kink.Based on the information available and device analysis, the cause for the reported issues and analyzed anomalies could not be definitively determined.
Event or Problem Description
Analysis of the device revealed that the guide catheter shaft was broken.There were no clinical consequences reported to the patient.

• Brand Name: GUIDER/40XF/8FR/90CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6890443
• Report Number: 3008853977-2017-00033
• Device Sequence Number: 656359
• Product Code: DQY
• UDI-Device Identifier: 08714729202486
• UDI-Public: (01)08714729202486(17)190228(10)18897905
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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
• Report Date (Section B): 09/25/2017

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: 02/28/2019
• Device Model Number: H965100440
• Device Catalogue Number: H965100440
• Device Lot Number: 18897905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1