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

Model Number 86700

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Age or date of birth: no information available.Not applicable for this device.Explant date/implant date: not applicable for this device.The visions pv.018 catheter was returned for evaluation; however, device evaluation is anticipated, but not yet begun.Correction/removal number/recall: do not apply to this submission.

Event Description

It was reported that during a peripheral procedure, while retracting the visions pv.018 catheter, it got stuck at the distal end of the non-manufacturer's sheath and broke off inside the patient.A snare was used to remove the distal tip, but it embolized and went to the right lung.The physician felt that the distal tip separated when the sheath was making an acute angle as it was meeting the catheter.The patient was transferred to ir to snare from the right lower lobe, but slipped off of the snare.It was then decided to leave the separated distal tip in place as the patient was asymptomatic.The patient is in stable condition and was discharged as expected.This adverse event and product problem is being submitted because the visions catheter separated in two pieces.Additional intervention was performed; however, the distal tip was retained in the patient.

Manufacturer Narrative

Block h3: the device was visually and microscopically inspected.The distal part of the catheter including the expanded single lumen (esl), the scanner, and the tip were not returned.A zippered tear was observed starting from the guidewire exit port to the damaged section where microcables were exposed with sharp edges.Block h6: the probable cause of the separation is the damage occurred during use of the device.Device manipulation, impact, and applied pressure associated with use and handling can further affect the integrity of the device.

• 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
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14190537
• MDR Text Key: 294605076
• Report Number: 3008363989-2022-00025
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)220121(17)240121(10)0302488540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302488540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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: BERENSTEIN GUIDE CATHETER.; UNK MFG AND SIZE: GUIDE WIRE.; UNK MFG: 7F INTRODUCER SHEATH.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Patient Race: White