MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700J

Device Problem Material Separation (1562)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.No information available.Not applicable for this device.Not applicable for this device.Country is (b)(6).The record's reportability decision was incorrectly documented, resulting in a late mdr.The visions pv.018 catheter was visually and microscopically inspected.The distal tip was broken in two parts with rough edges of malleable shaft material observed.The two broken portions of the distal tip were accounted for and measured at 14 mm.The probable cause of the reported tip separation is damage in use, likely from excessive pulling force, as evidenced by the stretched material observed at the distal tip.Strain, impact, and forces associated with handling may affect the integrity of the device.Do not apply to this submission.

Event Description

It was reported that during a peripheral procedure for an evt treatment of the calcified iliac artery, the manufacturer's catheter separated 2 cm from the distal tip with no force applied during removal from the patient.When it separated, the distal tip was just outside of the hemostasis valve of the sheath.No patient injury reported.This product problem is being submitted because a distal tip separation has a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Block d10: concomitant brand name and size received.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11988007
• MDR Text Key: 255982073
• Report Number: 2939520-2021-00043
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002794
• UDI-Public: (01)00845225002794(17)220630(10)0301960753(90)989609001011
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 86700J
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0301960753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLADIUS: 0.018 GUIDE WIRE; PARENT CROSS: 7F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH