MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .035 (NON-HOSPITAL); CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Codes	Entrapment of Device (1212); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv catheter has not been returned for evaluation, thus no returned product investigation was performed.
Event or Problem Description
It was reported that during a therapeutic peripheral procedure, the manufacturer's catheter shaft ripped apart, but remained intact to the internal wires.During pullback, the catheter was unable to be removed; therefore, the catheter was cut mid shaft.A second access location in the upper arm was required, and used a snare to remove the distal half of the catheter, successfully.No piece of the catheter was left in the patient.The procedure was completed with a non manufacturer's balloon and no patient injury reported.This adverse event and product problem is being submitted because the distal portion of the manufacturer's catheter shaft ripped apart and additional intervention was performed to retrieve the catheter.
Additional Manufacturer Narrative
Block d9 & h3: visions pv.035 catheter was returned for evaluation.Block h3:the catheter was returned separated in two parts (purposely cut by the user) at the distal shaft.The device was visually and microscopically inspected and found multiple kinks on the shaft and tip of the catheter.Block h6: the reported failure of the catheter shaft ripped apart and exposing the wires is at the same location where the user cut the device; therefore, the damage could not be determined.However, device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.
Additional Manufacturer Narrative
Block g: updated the city from costa rica to alajuela.Updated the country from united states (usa) to costa rica (cri).
Additional Manufacturer Narrative
Block d4: udi number was inadvertently missed.

• Brand Name: VISIONS PV .035 (NON-HOSPITAL)
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive #500; #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business pa; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12921677
• Report Number: 3008363989-2021-00027
• Device Sequence Number: 12176764
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(11)210610(17)230610(10)0302294825
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0302294825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 04/07/2022; 04/15/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/24/2022; 04/08/2022; 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MERIT: 8F INTRODUCER SHEATH.; MERIT: LAUREATE GUIDE WIRE, SIZE UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White