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

Model Number	10185P
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a coronary diagnostic procedure in the body post normalization and pre measurement, the manufacturer's guidewire was stretched.A new guidewire was used to complete the procedure.No patient injury reported.The returned device was visually and microscopically inspected.A large portion of the distal coil was stretched and the core wire was exposed, as a result a sharp edge was observed.There is no missing parts detected.This product problem is being submitted because the exposed core wire with a sharp edge has a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Age or date of birth-ethnicity: no information available.Relevant tests/laboratory data, including dates & other relevant history, including preexisting medical conditions: no information available.Suspect products: not applicable for this device.Implant date & explant date: not applicable for this device.Initial reporter name and address: & report source: country is (b)(6).The probable cause of the reported damage is excessive mechanical strain, as evidence by the stretching of the distal coil and the exposed core wire.Device manipulation, impact, and applied pressure associated with use and handling can further affect the integrity of the device.Recall (if recall number is given) or correction/removal number (if given) & correction/removal number: do not apply to this submission.

• Brand Name: VERRATA 10185P
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12411271
• Report Number: 3008363989-2021-00012
• Device Sequence Number: 14735217
• Product Code: DQX
• UDI-Device Identifier: 00845225002879
• UDI-Public: (01)00845225002879(17)230831(10)0301997706(90)989609001231
• Combination Product (Y/N): Y
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 07/13/2021

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: 08/31/2023
• Device Model Number: 10185P
• Device Catalogue Number: 400-0300.38
• Device Lot Number: 0301997706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/01/2021
• 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: 6F INTRODUCER SHEATH, MFG UNK; UNK MFG AND SIZE: GUIDE CATHETER