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

Model Number H749163913021

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: 2134265-2016-03900.It was reported that thrombosis occurred.The target lesion was located in the coronary artery.A 5f 155cm impulse guide catheter was selected for use.During a cardiac catheterization procedure, it was noticed that the impulse guide catheter had caused thrombosis in a few instances.No further patient complications were reported.

• 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: 5648041
• MDR Text Key: 44984939
• Report Number: 2134265-2016-03901
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: H749163913021
• Device Catalogue Number: 16391-302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other