MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/40 XF/8FR/100 CM; CATHETER, PERCUTANEOUS

Catalog Number	M003101440
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During treatment of a p-com anuerysm, the physician reported that the guide catheter hub was leaking.The physician believes that air bubbles were inserted into the guide catheter due to the hub leak and it might cause air embolism to the patient.No patient adverse consequences were reported.Additional information recieved, indicated, that as of today, the patient has no neurological deficits and is in good condition.
Additional Manufacturer Narrative
Analysis of the returned device revealed that guide catheter distal tip lumen was slightly compressed.The guide catheter was also kinked and compressed on its distal shaft.No anomalies were observed with the guide catheter proximal shaft and proximal lumen.The guide catheter distal end was plugged with a mandrel and flushed with water.The fluid was leaking between hub and proximal shaft.While the manufacturing records did not reveal that the device failed to meet specifications, the observed catheter hub leak is believed to be supplier related.The manufacturer continues to investigate the matter.However, based on the information currently available, there was no patient adverse consequences associated with the alleged introduction of air and it could not be replicated during functional testing; therefore, an assignable cause of undeterminable was assigned.
Event or Problem Description
During treatment of a p-com anuerysm, the physician reported that the guide catheter hub was leaking.The physician believes that air bubbles were inserted into the guide catheter due to the hub leak and it might cause air embolism to the patient.No patient adverse consequences were reported.Additional information received, indicated, that as of today, the patient has no neurological deficits and is in good condition.

• Brand Name: GUIDER/40 XF/8FR/100 CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6530922
• Report Number: 0002134265-2017-30023
• Device Sequence Number: 10847608
• Product Code: DQY
• UDI-Device Identifier: 08714729244318
• UDI-Public: (01)08714729244318(17)190228(10)18938659
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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 Catalogue Number: M003101440
• Device Lot Number: 18938659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR