MAUDE Adverse Event Report: VOLCANO CORPORATION RECONNAISSANCE PV .018 OTW DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	018OTW
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a reconnaissance catheter was used in a diagnostic peripheral procedure in a severely calcified distal sfa.During insertion of the catheter through an introducer sheath and over a non-philips guidewire, the guidewire got caught and unable to exit out of the catheter guidewire exit port (y-connector).The catheter was removed, re-flushed, and reinserted into the patient, but did not resolve.Therefore, the physician cut off a piece of the y-connector in order to allow guidewire movement.After, the catheter was able to advance further down the guidewire toward the stenosis.There was no patient injury reported.This adverse event and product problem is being submitted because a non-philips guidewire got stuck inside the reconnaissance catheter, and additional intervention was required for guidewire movement.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no information available.Block b6: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the reconnaissance catheter was not returned for evaluation, thus no returned product investigation was performed.Block h6: per ifu precautions, do not cut, crease, knot, or otherwise damage the catheter.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.
Additional Manufacturer Narrative
Block h3: the reconnaissance catheter was visually and microscopically inspected.The proximal portion of the y-connector was missing with sharp edges of non-malleable material observed.During functional testing, a laboratory guidewire was inserted through the device and passed the guidewire movement test with no resistance encountered.Block h6: although a laboratory guidewire was able to pass through the device with no resistance, the probable cause of the movement issue could not be established.The portion of the "y" connector that was cut off by the user was not returned; therefore, it could not be conclusively determined when and how the cause of the failure occurred.Investigation conclusion code #18 remains appropriate as indicated in the initial mdr.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: RECONNAISSANCE PV .018 OTW DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 17852702
• Report Number: 3008363989-2023-00047
• Device Sequence Number: 17813232
• Product Code: OBJ
• UDI-Device Identifier: 00845225003067
• UDI-Public: (01)00845225003067(11)230630(17)260630(10)0302937771
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K200410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 06/30/2026
• Device Model Number: 018OTW
• Device Catalogue Number: 018OTW
• Device Lot Number: 0302937771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/02/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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: GUIDE WIRE MFG AND SIZE UNK; TERUMO: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown