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

Model Number	81234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
From initial mdr submitted on 10/12/2018 (mfr report # 2939520-2018-00132): this case was reviewed and investigated according to the manufacturer''s policy.It was reported, during an after use inspection of the manufacturer''s diagnostic device, it was observed the distal tip glue was coming off from the transducer.Additional information provided the procedure was an av access venous case.After the first run the physician observed the tip appeared as though it had delaminated or that glue had separated from the device.The tip was not deformed nor separated from the device.The procedure was successfully completed with a second of the same make and model.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.This product problem is being reported because there is a potential for harm if material is missing from the device.From supplemental mdr submitted on 12/26/2018 (mfr report # 2939520-2108-00132): this case was reviewed and investigated according to the manufacturer''s policy.This follow-up report (# 1) is being submitted to report device analysis observations for manufacture''s device.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: attempts to obtain patient information have been unsuccessful.Block b5 & g2 & h2: per fda email notification received on 05/10/2023, a supplemental follow-up is required to correct the mfr report # that was filed in supplemental 1, submitted on 12/26/2018: mfr report # corrected from 2939520-2108-00132 to 2939520-2018-00132.Per fda representative, the correction will be addressed as an initial mdr, which will combine the initial mdr and supplemental 1 that was submitted under registration number 2939520-2018-00132/2939520-2108-00132.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block g3: date fda notified philips to file a correction to supplemental 1.Block h3: visual and microscopic inspection were performed on the returned device.A portion of adhesive was missing.Block h6: the probable cause of the reported failure is the adhesive was damaged during first use.Strain, impact, and forces associated with use can affect the integrity of the device.However, it could not be determined how the device was damaged.Blocks h7 & 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.

• Brand Name: VISIONS PV .035 (NON-HOSPITAL)
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• 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 ; 858720-4063
• MDR Report Key: 16945154
• Report Number: 3008363989-2018-00132
• Device Sequence Number: 6554982
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(17)200731(10)0301481405(90)989609000971
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0301481405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER MFG AND SIZE UNK.; GUIDEWIRE, MFG AND SIZE UNK.; INTRODUCER SHEATH MFG AND SIZE UNK.
• Patient Sex: Unknown