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

Model Number H749393120SR0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Bsc id: (b)(4).Tw#: (b)(4).

Event Description

It was reported that shaft separation occurred.The totally occluded target lesion was located in the severely calcified mid right coronary artery (rca).A stingray lp catheter was selected for use.During procedure, the stingray catheter was advanced through the 7f non-bsc guide catheter into the subintimal mid rca, however the stingray balloon was unable to cross the lesion.As the catheter was being pulled back from the patient¿s body, it was noted that the stingray got caught on the distal edge of the guide catheter and separated from the shaft at the proximal end of the balloon.The lesion was then dilated and the procedure was completed with another stingray catheter.No patient complications were reported and patient¿s status was fine.

• Brand Name: STINGRAY LP 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: 7671138
• MDR Text Key: 113504794
• Report Number: 2134265-2018-06303
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152401
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: H749393120SR0
• Device Lot Number: 21508874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2017
• 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