MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY

Model Number P4044

Device Problems Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician attempted to use a silverhawk btk atherectomy device with a 6fr non-medtronic sheath and 0. 014 non-medtronic guidewire during treatment of an 80mm soft tissue cto (chronic total occlusion-100%) in the patient¿s mid right popliteal artery. Slight vessel calcification is reported. Artery diameter reported as 4mm. Ifu was followed. The vessel was not pre-dilated. It is reported that after running the device and pulled out of the body, a black string like substance was encountered coming out of the cutter window. The observed material appeared to be fibrous. Unclear if this was part of the device. The device was not wiped down between insertions. The cutter was inside housing when removed. When removed from patients, all parts of device were accounted for. The device was removed safely. A replacement hawk one device was opened to complete the procedure. No patient injury reported.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11929667
• MDR Text Key: 254041660
• Report Number: 9612164-2021-02162
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: P4044
• Device Catalogue Number: P4044
• Device Lot Number: 0010468763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage