MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS GLIDELIGHT LASER SHEATH

Model Number 500-303

Device Problem Physical Resistance (2578)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Tissue Damage (2104)

Event Date 01/08/2015

Event Type  Death  

Event Description

This was a lead extraction procedure to remove one rv icd lead because of signs of failure including noise and rising impedance (class iia indication for extraction).The lead (bsc 0184, implanted 106 months) was prepped with an lld #2 and a 14f glidelight, no outer sheath, was used to lase.The laser sheath was unable to progress beyond the proximal coil, so the physician upsized to a 16f glidelight, no outer sheath, and was successfully able to advance past the proximal coil and the lead tip released from the rv.Resistance was then encountered in the svc when approaching the svc/ra junction.The laser sheath was manually advanced 4-5 cm before lasing was resumed.The lead was extracted successfully.While inserting the wire to place a new rv pacing lead, the patient's systolic blood pressure dropped from 104 to 84, then to low 40s.A pericardiocentesis was performed and the patient was transferred to the or for a sternotomy.A tear from the innominate to the svc/ra junction was discovered, however it was unclear where the tear originated (although it was suspected that it originated in the svc/ra junction).The vessel wall was paper thin and "unraveled" during the repair which prevented suturing and utilization of bypass.It is also unclear whether the injury occurred from lasing or from manual advancement of the laser sheath in the svc.Unfortunately, all efforts to save the patient were unsuccessful and the patient did not survive the intervention.

Manufacturer Narrative

(b)(4).The device involved in this event is expected to be returned for evaluation.A follow-up report with results of the evaluation will be sent upon completion of the investigation.Placeholder.

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.It was noted by the physician during the attempted repair of the injury that the vessel was paper thin and "unraveled" during the repair which did not allow for suturing or bypass of the vessel.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: GLIDELIGHT
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4453066
• MDR Text Key: 5426794
• Report Number: 1721279-2015-00008
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/22/2016
• Device Model Number: 500-303
• Device Catalogue Number: 500-303
• Device Lot Number: FGC14D22A
• 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: 04/22/2014
• 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: BSC 4538 LV LEAD (IMPL 96 MON); LLD X2; BSC 0184 RV ICD LEAD (IMPL 96 MON); 14F GLIDELIGHT; BSC 4470 RA LEAD (IMPL 96 MON)
• Patient Outcome(s): Death
• Patient Age: 77 YR
• Patient Weight: 86