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

Model Number	560-011
Medical Device Problem Codes	Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight unavailable.The manufacturer is awaiting the return of the device for evaluation, but has not yet received it.
Event or Problem Description
It was reported to a philips representative two days post-procedure that a lead extraction procedure commenced to remove two leads: a right atrial (ra) and right ventricular (rv) lead due to bacteremia.The physician chose to use a spectranetics 11f tightrail sub-c rotating dilator sheath to extract the lead.While attempting to remove the ra lead, it was reported that the tightrail device became stuck on the lead.The problem occurred when the attempt to remove the device from the lead pulled off the insulation of the lead and could not be removed.The physician had to cut the lead in order to remove the device.It was reported that both leads were extracted successfully with no reported patient harm.This report is being submitted due to the potential for serious injury if the event were to recur.The manufacturer is anticipating return of the device for evaluation, but has not yet received it.
Additional Manufacturer Narrative
D10): device returned to manufacturer for evaluation on 07 july 2020.H6): method, results and conclusions codes populated now that device evaluation is complete.Device evaluation: the device was returned and initially evaluated on 08 july 2020, with final evaluation performed on 22 july 2020, by a cross functional engineering team.It was found that the blades were retracted and in the proper position and the shaft of the device was slightly bent to the left.With the handle halves separated, biologics were present throughout the inside and outside of the device.All 4 trigger tabs showed minimal to normal wear.The barrel and sleeve were in good condition.After x-ray was performed on the device on (b)(6) 2020, nothing was found within the device and no abnormalities of the inner coils were seen.After putting the device back together, trigger pulls were performed.No abnormalities were felt or seen with a series of trigger pulls.With no deficit noted with the trigger pulls and no damage observed throughout the device, it appears that a combination of heavy calcification and biological build-up inside the inner shaft caused the experienced 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
• MDR Report Key: 10194469
• Report Number: 1721279-2020-00135
• Device Sequence Number: 16996191
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)210503(10)FRP19E03A
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP19E03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ST. JUDE MEDICAL 1699TC RA PACING LEAD; ST. JUDE MEDICAL 1888 RV PACING LEAD
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005