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

Model Number	560-011
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unk.Relevant tests/laboratory data unk.The device was not returned, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) icd lead and right atrial (ra) lead due to severe tricuspid regurgitation with the icd lead, causing worsening symptoms.Spectranetics lead locking devices (llds) were inserted into the leads to provide traction, and a spectranetics 13f tightrail rotating dilator sheath was used during the procedure.The ra lead was successfully removed.While attempting to remove the rv lead using a spectranetics 11f tightrail sub-c rotating dilator sheath, the device became entangled on the lld present in the rv lead.The operator had to cut the lld distal to the tightrail device in order to free the lead.A (b)(4) bulldog lead extender was then used on the rv lead to complete the procedure.The patient survived the procedure with no reported harm.This report captures the tightrail sub-c device which became entangled on the lld in the rv lead, requiring intervention for lead removal.
Additional Manufacturer Narrative
D9): the device was returned to the manufacturer on 21 dec 2021.G3): the device evaluation and investigation were completed on 26 jan 2022.H3): device evaluation: the device was returned and evaluated by a cross functional team.Lead insulation was seen coming out of the device''s distal tip and suture was seen coming out of the proximal end of the device.The distal 2 inches of the device''s shaft was crepitous.Pulling from the proximal end of the device, suture and the lld were removed.However, while pulling, the lld broke inside the tightrail.With the proximal end of the lld removed from the device, it was seen that the lld''s capture assembly was the most proximal structure, confirming the proximal and distal ends of the lld were not returned with the tightrail device.Looking at the tightrail device, the internal mechanisms were in working condition, and although resistance was felt, the drive shaft was able to be manually actuated.The device was soaked and cross sectioned.Still, the lead could not be pulled out through the tightrail''s distal tip, so the inner coils of the tightrail device were cut open.8.75 inches of lld, lead jacket (insulation) and lead were pulled out of the inner diameter of the tightrail.Minimal to no biologics were seen around the lead or within the tightrail''s coils after removing the lead.It was determined the inner lumen space of the tightrail drive shaft was taken up by the lead jacket, indicating the 11f was undersized in comparison to the lead.This has been determined to be a use related failure.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING 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: 12957204
• Report Number: 1721279-2021-00230
• Device Sequence Number: 14815094
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)230920(10)FRP21J20A
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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 Expiration Date: 09/20/2023
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP21J20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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: COOK MEDICAL BULLDOG LEAD EXTENDER; RA LEAD MANUFACTURER AND MODEL UNK; RV ICD LEAD MANUFACTURER AND MODEL UNK; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White