MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 16F GLIDELIGHT

Model Number 500-303

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Injury (2348)

Event Date 12/15/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one class ii functional / advisory rv icd lead (sjm 7000, implanted 89 months).The lead was prepped with an lld and a 14f glidelight with visisheath was initially used, however resistance was met at the proximal coil so the physician upsized to a 16f glidelight (without outer sheath).Progression was smooth until close to the svc/ra junction where resistance was encountered.The physician pulled back the laser sheath to add an outer sheath, however the patient's blood pressure dropped to 50s systolic after the catheter was withdrawn.A sternotomy was performed and a 1 cm tear just above the svc/ra junction was discovered where the lead was calcified and "a part of the svc wall." the injury was repaired and it was decided to cut and cap the lead as removal of the lead would require reconstruction of the svc.

Manufacturer Narrative

The device involved in this complaint is expected to be returned for evaluation.If returned, a follow-up report will be filed.There is no allegation or evidence that the device malfunctioned in any way.

Manufacturer Narrative

The device involved in this event was returned and evaluated by a cross-functional engineering team.A visual inspection of the device found no issues with the device (the device was in perfect condition).A review of the lhr did not indicate any manufacturing issues that would have contributed to the event.There is no allegation or evidence of device malfunction.The lead had calcifed and adhered to the svc wall which resulted in the injury during the attempted extraction.(b)(4).

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 16F GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4376385
• MDR Text Key: 20756101
• Report Number: 1721279-2014-00222
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• 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,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/11/2015
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC13J11D
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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 VISISHEATH DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ); SJM 7000-65CM RIATA RV ICD LEAD (IMPL 89 MON); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 110