MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H74908526401

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a 5f pig 100cm expo guide catheter with side hole gave off a jet when they did the lv gram instead of a spray.The procedure was completed with this device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for analysis.Evaluation of the returned device revealed that there was no damage or irregularities noted to the hub and the shaft was flattened 5mm in length 3cm from the tip.Functional testing was completed by flushing a 20cc water filled syringe through the expo.There were no leaks found during functional testing.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a 5f pig 100cm expo guide catheter with side hole gave off a jet when they did the lv gram instead of a spray.The procedure was completed with this device.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4488685
• MDR Text Key: 15344779
• Report Number: 2134265-2015-00883
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

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 Model Number: H74908526401
• Device Catalogue Number: 08526-40
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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