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

Model Number 86700J

Device Problem Material Separation (1562)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Country is (b)(6).The probable cause of the missing adhesive is damage during use.Device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.

Event Description

It was reported that during a therapeutic peripheral procedure, the manufacturer's catheter's image disappeared during the first imaging.Another manufacturer's catheter was used to complete the procedure.No patient injury was reported.The returned device was visually and microscopically inspected.There were portions of adhesive missing at the expanded single lumen (esl).This product problem is being submitted for the missing adhesive.There is a potential for harm if the malfunction were to reoccur.

Manufacturer Narrative

Block d4: updated the udi number from (b)(4).

• Brand Name: VISIONS PV .018
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: in young rock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12840696
• MDR Text Key: 285536244
• Report Number: 3008363989-2021-00029
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002794
• UDI-Public: (01)00845225002794(11)210602(17)230602(10)0302287935
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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: 06/02/2023
• Device Model Number: 86700J
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302287935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK MFG AND SIZE: GUIDEWIRE.; UNK MFG AND SIZE: INTRODUCER SHEATH.