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

Model Number H74916391022

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Chest Pain (1776); ST Segment Elevation (2059)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It was reported that during a diagnostic procedure an air embolization occurred.A 5f impulse guide catheter was being used in the right coronary artery (rca).The physician aspirated the catheter with 10-15 mls of blood back before a test injection which caused an embolization.Following this a further 2-3 aspirations continued to produce a large volume of air.All connections were checked and found to be secure.The procedure was not completed due to this event.The patient was required to stay overnight.No further patient complications were reported and the patient's status is stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient experienced acute chest pain with inferior st elevation.For 5-10 minutes the timi 1 flow was noted in the distal rca.This was resolved within 20 minutes.The air embolization was also treated with nitrates.

Manufacturer Narrative

(b)(4).A microscopic examination of the returned complaint device revealed no damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was further reported that the patient experienced acute chest pain with inferior st elevation.For 5-10 minutes the timi 1 flow was noted in the distal rca.This was resolved within 20 minutes.The air embolization was also treated with nitrates.

• Brand Name: IMPULSE 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: 4814965
• MDR Text Key: 5833477
• Report Number: 2134265-2015-03259
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: H74916391022
• Device Catalogue Number: 16391-02
• Device Lot Number: 0050876712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/02/2015; 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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 Outcome(s): Other