MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-TANDEM LASER ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 472-110

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

Patient Problems Iatrogenic Source (2498); Vascular Dissection (3160)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.

Event Description

A peripheral procedure commenced on (b)(6) 2020 to treat a severely calcified lesion in the mid superficial femoral artery (sfa). This procedure was part of a postmarket study taking place in (b)(6), and a philips representative became aware of the event on 01 dec 2020. The physician chose to use a spectranetics turbo-tandem laser atherectomy catheter to treat the lesion. It was reported that after use of the turbo-tandem device, a dissection (grade a) was observed. A plain old balloon angioplasty (poba) (non-drug coated) was used to treat the dissection, the procedure was completed, and the patient survived the procedure. There was no alleged malfunction of the turbo-tandem device in use during the procedure. This report is being conservatively submitted because it cannot be confirmed at this time whether the turbo-tandem device was being used in the area in which the dissection was observed.

• Brand Name: SPECTRANETICS TURBO-TANDEM LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE 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: 11055535
• MDR Text Key: 224245041
• Report Number: 1721279-2020-00263
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132020248
• UDI-Public: (01)00813132020248(17)200803(10)FBY18G18A
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K094036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/03/2020
• Device Model Number: 472-110
• Device Catalogue Number: 472-110
• Device Lot Number: FBY18G18A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/22/2020 Patient Sequence Number: 1