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

Model Number 500-013

Device Problem Physical Resistance (2578)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Pericardial Effusion (3271)

Event Date 06/15/2015

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one ra and one rv lead due to infection.The rv lead (sjm 1999, impl 60 months) was extracted successfully using traction only.The ra lead (sjm 2088tc, impl 60 months) was prepped with an lld-ez.The physician started the extraction using a 12f sls, however progress stopped at the proximal electrode.The physician upsized to a 14f sls, however, it also stalled at the same location.The physician then used only the outer sheath of the 12f sls and it progressed successfully, so the physician tried to extract the ra lead with the sheath, however he encountered resistance again.A 16f sls was then used but it was not successful in extracting the lead.It was at this time that the patient's blood pressure decreased to 60/40 and a small effusion was confirmed using tee.A sternotomy was performed and an injury in the ra/ivc junction was found.During the open procedure, the ra lead was removed manually and the injury was repaired.The patient survived the intervention.According to the physician, the patient has a history of mitral and aortic valvuloplasty after pacemaker lead implantation in (b)(6) 2010.During the valvuloplasty procedure, an artificial heart-lung apparatus was used and the ra/ivc incision area where the cannula was placed was sutured after the procedure was completed.At that time, when the ra/ivc was sutured, the ra lead was probably sutured into ra/ivc area, therefore contributing to the difficulty extracting the lead and the subsequent injury that occurred.

Manufacturer Narrative

(b)(4).The devices involved in this complaint are expected to be returned for evaluation.A follow-up report will be submitted when the results of the evaluation are available.

Manufacturer Narrative

The 16f sls was returned for evaluation by a cross-functional engineering team.There was no problem found with the device.The other sls devices used during the procedure (12f and 14f) were also returned and evaluated.Small kinks associated with shipping were noted upon return, however there was nothing wrong with the devices that would cause/contribute to the injury that occurred.A review of the devices'' manufacturing histories also revealed no issues during the manufacturing process that would cause/contribute to the injury that occurred.Vessel perforation is an inherent risk of the procedure.There is no allegation or evidence of device malfunction.

• Brand Name: SPECTRANETICS LASER SHEATH II
• Type of Device: 16F SLS
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: jessica hearn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4876474
• MDR Text Key: 5863789
• Report Number: 1721279-2015-00101
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/11/2017
• Device Model Number: 500-013
• Device Catalogue Number: 500-013
• Device Lot Number: FKK15B11A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• 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 SLS II LASER SHEATH; SJM 1999-52 RV PACING LEAD (IMPL 60 MON); SPECTRANETICS LEAD LOCKING DEVICE (LLD-EZ); SJM 2088TC-58 RV PACING LEAD (IMPL 60 MON); SPECTRANETICS 12F SLS II LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 66