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 Date 02/01/2016

Event Type  malfunction  

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

It was reported that a re-entry catheter was not visible under fluoroscopy.A stingray catheter was used to help treat a chronic totally occluded (cto) target lesion.When the physician inflated the stingray balloon catheter, it was noticed that the device was impossible to visualize under fluoroscopy.The physician was uncertain if the device was filled correctly or if there was something wrong with the stingray balloon catheter as he prepped the device himself and thought the device should had been visible.The stingray catheter was removed and re-prepped however, a new catheter was used to complete the procedure.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5469987
• MDR Text Key: 39419408
• Report Number: 2134265-2016-01219
• 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: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749M1000A0
• Device Catalogue Number: M-1000-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• 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: Initial
• Patient Sequence Number: 1