MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number UNKNOWN

Device Problem Filling Problem (1233)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 03/09/2016

Event Type  malfunction  

Event Description

Laceration during lead extraction at svc/ra junction.After suspected snowplowing, the physician decided to upscale to a 16 fr.Glidelight at the svc junction.A drop in bp was noticed.A tee was performed and found that the rv was not filling.A sternotomy was performed to repair a 4cm tear at the svc/ra junction.The patient survived the intervention.As of (b)(6) patient is awake and mobilizing.The physician was very specific regarding the patients unnaturally thin svc vessel wall.The atrial lead was removed and the ventricular lead was cut and capped with an lld inside.Concomitant device report: 1721279-2016-00040.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: tresa osborne ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-225
• MDR Report Key: 5523125
• MDR Text Key: 41462416
• Report Number: 1721279-2016-00039
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2016

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 65