MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 88901

Device Problem Material Separation (1562)

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

Event Date 10/24/2023

Event Type  Injury  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.H6: the visions pv.035 catheter was not returned for evaluation, thus no returned product investigation was performed.H9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that a visions pv.035 catheter was used in a therapeutic peripheral procedure in a severely calcified proximal iliac vessel.During advancement to the lesion, approximately 6 mm of the distal tip separated inside the introducer sheath.The separated portion was suctioned successfully using a syringe.The procedure was completed with a new visions catheter.No patient injury reported.This adverse event and product problem is being submitted due to the tip separation, requiring intervention.

Manufacturer Narrative

Block h3: the visions pv.035 catheter was returned in three pieces.The distal tip separated approx.5.5 mm from the proximal tip, which aligns with the reported complaint of approx.6 mm.Additionally, the scanner body separated from the distal shaft, that likely occurred post-procedure since this was not reported by the facility.Both separated portions on the distal and proximal tip were slightly flattened near the breaking point.No missing material was observed.Block h6: the probable cause of the separated distal tip is damage during use/handling as evidence by the flattened section observed near the breaking point.Manipulation, strain, impact, and forces associated with use can affect the integrity of the device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: VISIONS PV .035 DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 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 kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-406
• MDR Report Key: 18164791
• MDR Text Key: 328480295
• Report Number: 3008363989-2023-00051
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(11)230421(17)250421(10)0302885182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153094
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88901
• Device Catalogue Number: 88901
• Device Lot Number: 0302885182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• 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: GUIDE CATHETER MFG AND SIZE UNK.; GUIDE WIRE MFG AND SIZE UNK.; TERUMO: 8F DESTINATION INTRODUCER SHEATH.
• Patient Outcome(s): Required Intervention