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

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Patient info: no information available.Attempts to obtain the information has not been successful.Relevant tests/laboratory data, including dates & other relevant history, including preexisting medical conditions no information available.Attempts to obtain the information has not been successful.Suspect medical device: not applicable for this device.Implant date & explant date: not applicable for this device.Device evaluated by mfr & evaluation codes: the visions pv.018 catheter was infectious and not returned for evaluation, thus no returned product investigation was performed.Recall (if recall number is given) or correction/removal number (if given) & correction/removal number: do not apply to this submission.

Event Description

It was reported that during a peripheral procedure during pullback, the manufacturer's catheter tip separated in the sheath.The tip was retrieved by removing the sheath.There was no additional intervention performed.The procedure was completed with a new manufacturer's catheter.The patient was discharged as expected in good condition.This product problem is being submitted because the tip separated.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Block e1: facility name updated from "dr.(b)(6)" to "(b)(6)".

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12464472
• MDR Text Key: 280766566
• Report Number: 3008363989-2021-00013
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)210526(17)230526(10)0302280594
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Exemption Number: 3008363989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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: 05/26/2023
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302280594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: GUIDEWIRE