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

Model Number	545-511
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient's date of birth, age unk a3): patient's gender unk a4): patient's weight unk a5a./5b.): patient''s ethnicity/race unk.B6): relevant tests/laboratory data unk b7): other relevant history unk d4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): the device was discarded, therefore investigation could not be completed and reported problem could not be confirmed.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 or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead.The traction platform used for the ra lead is unk, but a spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath and alternating between the ra and rv leads, the ra lead was ultimately extracted with no issues.Then, attempting to extract the rv lead with the same 16f glidelight, progress stalled at the top of the superior vena cava (svc).Switching to a spectranetics 11f tightrail rotating dilator sheath, advancement was reached 3-4 cm from the rv lead tip; however, the tightrail became stuck on the lead.Repeated traction attempts led to ectopic heart beats and intermittent drops in the patient's blood pressure (bp), concomitant with each traction pull.At that time, the lld in the rv lead snapped near the lld's proximal end, out of the patient's body (mdr #3007284006-2023-00098).To attempt removal and to expose the lld, the tightrail's outer jacket was incised (mdr #3007284006-2023-00093).An artery forcep was used to clamp the lld, thereby allowing a traction platform.Then, the lld, tightrail, and rv lead were extracted with no surgical intervention required.Upon removal of the rv lead, the patient's bp dropped significantly, and recovered slowly.The patient survived the procedure.The physician suspected that the drops in bp were a vagal response, and not as a result of an injury.This report captures the 11f tightrail which became entrapped on the lead, requiring intervention.
Additional Manufacturer Narrative
Udi related data quality updates only: d4): correction: removing primary di number from udi# field.The lot number was not provided, thus an entire udi# is unavailable.G3): on 09jul2024, the manufacturer received fda email correspondence identifying a discrepancy in the udi information (section d of the initial mdr).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.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 18369689
• Report Number: 3007284006-2023-00093
• Device Sequence Number: 7617284
• Product Code: DRE
• UDI-Device Identifier: 00813132020880
• UDI-Public: 00813132020880
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: RA LEAD MANUFACTURER/MODEL/TYPE UNK; RV ICD LEAD MANUFACTURER/MODEL UNK; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown