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

Catalog Number M003101440

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event 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.

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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6530922
• MDR Text Key: 74071925
• Report Number: 0002134265-2017-30023
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729244318
• UDI-Public: (01)08714729244318(17)190228(10)18938659
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K980453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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
• Patient Age: 70 YR