MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD-EZ

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/10/2014

Event Type  Injury  

Event Description

A frail (b)(6) year old male patient with an ra, rv, and lv lead was admitted for pocket infection and referred for extraction.This was a right-sided lead extraction procedure.The physician was able to remove the ra and lv leads (model #s unknown, both implanted 5 months) with minimal traction force only (no lead locking devices were used).The third lead to be extracted, the rv lead (mdt 6943, implanted 13 years), was prepped with an lld-ez and a 14f glidelight laser sheath was used for the extraction.The vessel was highly calcified, however, the physician was able to get through the svc without issue.As the glidelight made its way toward the atrium, it was clear that the vessel was highly calcified and the physician decided to withdrawal the glidelight in order to add a visisheath (outer sheath) to assist with the extraction and navigate through the dense adhesions.As the physician removed the glidelight, the patient coughed and the blood pressure dropped quickly.Based on the unexplained drop in pressure, the cardiac team was called.The chief anesthesiologist administered an epi drip and the pressure started to return.Venograms were conducted on both sides and it was determined that no injury had occurred.At this time, the physician elected to stop the case.The lead was cut and capped with the lld inside.The physician will bring the patient back another day to remove the lead.The patient was stable after the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4090741
• MDR Text Key: 4832144
• Report Number: 1721279-2014-00154
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/30/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14A30A
• Other Device ID Number: M204518062058010116FLP14A30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• 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: MEDTRONIC RA LEAD (MODEL UNKNOWN), IMPL 5 MON; MEDTRONIC SPRINT 6943 RV ICD (IMPL 13 YEARS); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; MEDTRONIC LV LEAD (MODEL UNKNOWN), IMPL 5 MON
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 45