MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY LP; CATHETER, PERCUTANEOUS

Model Number	10594
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was not resolved.The target lesion was located in the left anterior descending artery.A stingray lp was selected for use.The balloon was prepped correctly outside the body.During procedure, the balloon was inserted and inflated as normal; stick was performed with a wire with no problem.Subsequently, the wire was tried to swap with a pilot 200 but it could not exit through the stingray balloon catheter.The pilot 200 was then removed and reinserted but failed.Per physician, it was difficult to push the pilot through the stingray hub.A fresh pilot 200 was used and experienced the same resistance at the hub.The procedure could not be completed as planned with the stingray stick and swap technique due to wire resistance at hub and time or contrast exposure.No complications were reported and patient will return for further treatment.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was microscopically and visually examined.The stopcock was still attached to the device.There was contrast in the manifold port, and inflation lumen.Blood was present in the guidewire lumen.The balloon presented no issues.The device was soaked in a water bath to loosen and break up contrast and blood in the device.The device was functionally tested with a 0.014 stingray guidewire.The guidewire was inserted through both the tip and the manifold.When feeding the guidewire through the tip, resistance was felt at the manifold.The guidewire was removed and inserted through the manifold and resistance was found.Further inspection to the manifold showed there was a buckled guidewire lumen just above the strain relief.Product analysis confirmed the reported event.The buckled guidewire on the device is damage consistent with the reported resistance at the hub (manifold) while advancing a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the procedure was not resolved.The target lesion was located in the left anterior descending artery.A stingray lp was selected for use.The balloon was prepped correctly outside the body.During procedure, the balloon was inserted and inflated as normal; stick was performed with a wire with no problem.Subsequently, the wire was tried to swap with a pilot 200 but it could not exit through the stingray balloon catheter.The pilot 200 was then removed and reinserted but failed.Per physician, it was difficult to push the pilot through the stingray hub.A fresh pilot 200 was used and experienced the same resistance at the hub.The procedure could not be completed as planned with the stingray stick and swap technique due to wire resistance at hub and time or contrast exposure.No complications were reported and patient will return for further treatment.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11668605
• Report Number: 2134265-2021-04829
• Device Sequence Number: 3157253
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: 08714729903352
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: 10594
• Device Catalogue Number: 10594
• Device Lot Number: 0026112863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1