MAUDE Adverse Event Report: VERRATA 10185P; WIRE, GUIDE, CATHETER

Model Number	10185P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.(b)(6).The verrata 10185p wire has not been returned for evaluation, thus no returned product investigation was performed.
Event or Problem Description
It was reported that during a diagnostic coronary procedure after ifr measurements during pullback, the manufacturer's wire broke in two pieces within the introducer sheath, but able to be retrieved from the guide catheter without intervention.The procedure was completed with the suspect device.No patient injury reported, the patient received normal expected treatment and was discharged home.This product problem is being submitted because the manufacturer's wire separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Blocks d9, g3 & h3: the verrata 10185p wire was returned for evaluation.Block h3: the verrata 10185p wire was visually and microscopically inspected.The hypotube and microcables were broken in two parts with sharp edges noted.No missing material was observed.Block h6: the probable cause of the reported failure was damage in use.Inappropriate manipulation and strain on the wire can cause damage to the internal components and can result in the separation of the hypotube and microcables in two parts.

• Brand Name: VERRATA 10185P
• Common Device Name: WIRE, GUIDE, CATHETER
• MDR Report Key: 12585198
• Report Number: 3008363989-2021-00016
• Device Sequence Number: 3787903
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(11)210519(17)240519(10)0302279507
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 05/19/2024
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0302279507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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: UNK MFG AND SIZE: INTRODUCER SHEATH; UNK MFG AND SIZE: INTRODUCER SHEATH