MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS VISISHEATH DILATOR SHEATH

Model Number 501-114

Device Problem Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Patient's medical history not available from facility.

Event Description

Lm procedure due to pocket infection; extraction planned for 1 ra and 2 rv leads.Large amount of pus was suctioned from pocket; large amount of calcification was noted.Physician used 14f glidelight and visiwheath and successfully removed ra lead (heavy calcific adhesions were noted on lead).Physician then attempted removal of older rv lead with the same two above devices.Fourteen fr glidelight advanced to svc/atrial junction but could go no further.Visisheath then brought to where advancement had stopped.At this time, bp dropped.Outer sheath, then glidelight pulled back to innominate/svc junction; pericardial effusion noted; suspected svc/atrial junction tear.Rescue efforts implemented; sternotomy performed; location of injury confirmed.Successful repair of tear completed; leads removed; patient survived procedure.

• Brand Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Type of Device: VISISHEATH
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6508610
• MDR Text Key: 73329081
• Report Number: 1721279-2017-00070
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092378
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/10/2019
• Device Model Number: 501-114
• Device Lot Number: FMM17B10A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2017
• 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
• Treatment: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 62