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

Model Number	501-014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead to upgrade a dual chamber pacemaker to a crtd system.The patient was a congenital heart patient and did not have normal anatomy.A venogram showed venous occlusion and an unidentifiable (congenital) large vertical venous structure from the access point (subclavian) at the pocket, moving inferior.There was also a remnant of a previously extracted lead (date and model unknown) in the subclavian vein.Spectranetics lead locking devices (llds) were inserted into the ra and rv leads to provide traction.First, the physician attempted to remove the rv lead using a spectranetics 14f glidelight laser sheath and a spectranetics medium visisheath dilator sheath.With these devices, advancement was made to the superior vena cava (svc) region, but the rv lead was found to be adhered to the ra lead, and both leads pulled back and bunched up together in the right atrium and svc regions.The glidelight device could no longer be advanced.A wire was advanced through the glidelight device to obtain access for re-implantation of new leads.The ra lead was snared from the groin and attempt was made again to remove the ra removed with the 14f glidelight and medium visisheath devices, but the 14f glidelight could not pass the lead on lead binding site.There was much difficulty every time the 14f glidelight device passed the remnant lead present in the subclavian, as there was a lot of resistance.The physician then attempted to remove the rv lead, upsizing to a 16f glidelight and a large visisheath device.Tension was placed on the ra lead from the groin and significant resistance was encountered with the large visisheath in the subclavian area.The physician removed the devices from the patient, with the plan to proceed without the visisheath, but the patient started bleeding from the pocket site (subclavian vein) (mdr #).The bleeding could not be controlled, and the patient's blood pressure dropped.A figure of 8 intervention was attempted by the physician but was unsuccessful due to the amount of blood.The surgeon was paged and was in the room within approximately 5 minutes.Transesophageal echocardiography (tee) showed no effusion and an x-ray showed no blood around the lungs.Rescue interventions were implemented.The surgeons had a difficult time accessing the bleeding site (subclavian vein) as it was under the patient¿s clavicle but was eventually able to control the bleeding by suturing above the bleeding site.They were unsure if this was a sufficient repair, so the surgeons stayed scrubbed in while the physician re-implanted a new ra and rv lead.The surgeons advised to implant as quickly as possible so an lv lead was not attempted.The physician chose to abandon both the rv lead (mdr #1721279-2022-00035) and the ra lead (mdr #1721279-2022-00036), cutting and capping both leads/llds which remained in the patient.The physician did not attempt to unlock either lld prior to cutting and capping.The patient was stable by the end of the procedure.This report captures the large visisheath, the outermost device in the region when the subclavian bleeding (perforation) occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Relevant tests/laboratory data unk.The device was discarded, thus no investigation could be completed.

• Brand Name: SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13637432
• Report Number: 1721279-2022-00034
• Device Sequence Number: 2174653
• Product Code: DRE
• UDI-Device Identifier: 00813132020361
• UDI-Public: (01)00813132020361(17)231215(10)FVM21M15A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: 501-014
• Device Catalogue Number: 501-014
• Device Lot Number: FVM21M15A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMORAL SNARE MANUFACTURER UNK.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES.; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH.; ST. JUDE MEDICAL 1888TC RA PACING LEAD.; ST. JUDE MEDICAL 1888TC RV PACING LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White