MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STINGRAY CATHETER; CATHETER, PERCUTANEOUS

Model Number H749M1000A0

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were microscopically examined.The proximal marker and distal marker were present.There was no damage.Visual and microscopic inspection of the device was unable to identify any damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-10907.It was reported that the device was not visible under fluoroscopy.The chronic totally occluded target lesion was located in the right coronary artery (rca).A stingray catheter was selected for use.During procedure the device was inserted into the patient; however, it was noted that the device was unable to be visualized under fluoroscopy even after contrast was introduced.The procedure was not completed due to this event.No patient complications were reported.

• Brand Name: STINGRAY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6137186
• MDR Text Key: 61191747
• Report Number: 2134265-2016-10906
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: H749M1000A0
• Device Catalogue Number: M-1000-A
• Device Lot Number: 17708082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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