MAUDE Adverse Event Report: VOLCANO CORPORATION OMNIWIRE PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	89185J
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional 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.Blocks e1 & g2: country is poland.Block h3: the omniwire was returned for evaluation.Visual inspection found a stretched distal coil measuring approximately 5 cm proximal from the distal tip.The core wire was broken exposing a sharp edge, but remained intact to the device.Block h6: the probable cause of the sharp edge was likely damaged during removal/handling from the patient.Manipulation and strain on the wire can cause damage to internal and external components and can result in the reported failure.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.
Event or Problem Description
It was reported that an omniwire was used in a coronary diagnostic procedure.Post normalization, the wire was unable to advance; therefore, it was removed from the patient to change the shape.Upon removal, approximately 6-7 cm of the distal portion of the wire was stretched.A new wire was used to complete the procedure.No patient injury reported.During the product return evaluation, the core wire was exposed resulting in a sharp edge.This product problem is being submitted due to a sharp edge observed.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Block a2-a5: patient information added.Block b6 & b7: relevant tests/medical history added.Block d10: concomitant devices added.Block e4: updated from unk to no.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: OMNIWIRE PRESSURE GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 18084575
• Report Number: 3008363989-2023-00057
• Device Sequence Number: 7730504
• Product Code: DQX
• UDI-Device Identifier: 00845225003050
• UDI-Public: (01)00845225003050(11)230613(17)260613(10)0302925985
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K192886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 06/13/2026
• Device Model Number: 89185J
• Device Catalogue Number: 89185J
• Device Lot Number: 0302925985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: 6F: INTRODUCER SHEATH, UNK MFG; CORDIS: 6F JL GUIDE CATHETER; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White