MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE VESSIX; VESSIX¿ GUIDE SHEATH

Model Number UNK781

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that the guide sheath caused the balloon to slip when it was tightened.During the index procedure, post renal artery denervation was completed in left superior renal artery, left inferior renal artery and right superior renal artery using a vessix renal denervation catheter.The vessix¿ guide sheath and wire were pulled back and attempt to insert into the right inferior renal artery was made.However the vessel could not be engaged.The vessix catheter and the wire were removed.The vessix guide sheath was exchanged for an 8fr non-bsc sheath.Subsequently the non-bsc sheath was removed and the 7 fr vessix guide sheath was re-inserted.The vessix catheter was then inserted into the right inferior renal artery and denervation was completed.It was also reported that ¿the guide sheath caused the balloon to slip when it was tightened¿.It occurred every time the guide sheath was used in all four renal arteries.The procedure was completed with the same guide sheath.Post renal denervation was complete, inferior right renal angiogram revealed catheter induced spasm in renal artery.The patient was treated with intra-arterial nicardipine and nitroglycerine followed by balloon inflation at low pressure using an emerge balloon.The event was considered resolved.

• Brand Name: VESSIX
• Type of Device: VESSIX¿ GUIDE SHEATH
• 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: 6280856
• MDR Text Key: 65860584
• Report Number: 2134265-2017-00270
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK781
• Device Lot Number: 21807023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• 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
• Patient Age: 51 YR