MAUDE Adverse Event Report: SPECTRANETICS CORPORATION VISISHEATH DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Great Vessel Perforation (2152)

Event Date 10/02/2023

Event Type  Death  

Manufacturer Narrative

B6): relevant tests/laboratory data unk.H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels, great vessel perforation and death are known risks of complication with use of the visisheath device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function and occlusion.A left ventricular (lv) lead was present in the patient as well, but was not targeted for extraction.Spectranetics lead locking devices (lld ezs) were inserted into the ra and rv leads to provide traction.A stylet was placed within the lv lead to provide stability, since it was not being removed.Beginning with a spectranetics 16f glidelight laser sheath and a spectranetics large visisheath dilator sheath on the rv lead, advancement was made into the ra before resistance was encountered.Efforts switched to the ra lead with the glidelight and visisheath, and attempts were made to add a wire through the glidelight to gain access, but were unsuccessful.The glidelight was removed, leaving the visisheath within the patient, and a wire was placed through the visisheath for access.Using only the visisheath, attempts to advance could not be achieved, and the patient's blood pressure began to drop.When the visisheath was removed, the blood pressure dropped even more.Transesophageal echocardiography (tee) did not initially detect an effusion; however, it was noted that the rv was not moving and groin pulses were absent.Rescue efforts began, including chest compressions and rescue balloon.At that time, a large posterior effusion was detected and a sternotomy was performed.A single perforation was discovered, extending from the innominate, continuing to almost the entire length of the superior vena cava (svc).The rescue balloon could only occlude a portion of the perforation, and repair attempts began with the patient off-pump.The tissues continued to tear during repair efforts, and ultimately, the perforation was deemed so large that it was irreparable.Adequate blood volume could not be maintained in the patient, and despite manual cpr to the heart, the patient did not survive.This report captures the visisheath, the last device in use in the area when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: VISISHEATH DILATOR SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18007621
• MDR Text Key: 326553760
• Report Number: 3007284006-2023-00047
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092378
• 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: 10/25/2023

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2023
• 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
• Treatment: ABBOTT 1571 RV ICD LEAD.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES (LLD EZS).; ST. JUDE MEDICAL 1056T LV LEAD.; ST. JUDE MEDICAL 1888 RA PACING LEAD.
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White