MAUDE Adverse Event Report: VOLCANO CORPORATION VISIONS PV .035 DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	88901
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a2: date of birth not available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the visions pv.035 catheter was not returned for evaluation, thus no returned product investigation was performed.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 a visions pv.035 catheter was used in a therapeutic peripheral procedure in a moderately calcified proximal iliac vessel.Prior to use of the visions catheter, a balloon angioplasty, then stenting, followed by a post balloon angioplasty were performed.After, the visions catheter was used and during removal, it got caught in the patient anatomy and the distal tip separated.The separated portion was removed with a snare.Angiogram confirmed no piece was retained in the patient.The patient was discharged as expected with no injury reported.This adverse event and product problem is being submitted due to the tip separation, requiring intervention (snare).
Additional Manufacturer Narrative
Block h3: the visions pv.035 catheter was returned without the distal portion (includes distal tip, distal fillet, and scanner body) of the catheter.The proximal portion (includes the proximal fillet, catheter shaft, y-connector, and a portion of the connector cable) that was returned measured approximately 89.6cm from its distal end to the y-connector.Visual inspection found that the catheter separated at the proximal fillet.The inner member broke within the proximal fillet, and was still attached to the polyamide.At the location of the separation (proximal fillet), no sharp edges were observed.It is likely that the distal portion measured approximately 1.9 cm (max.Spec) which is within the overall catheter working length (90 +/- 2.5 cm) when including the returned proximal portion of 89.6 cm.Block h6: the probable cause of the catheter separation is damage during use due to the device being caught on the patient anatomy, and required some degree of force to remove.Manipulation, strain, impact, and forces associated with use can also affect the integrity of the device.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 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: 17546229
• Report Number: 3008363989-2023-00034
• Device Sequence Number: 6429990
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(11)230303(17)250303(10)0302847771
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 03/03/2025
• Device Model Number: 88901
• Device Catalogue Number: 88901
• Device Lot Number: 0302847771
• 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: 08/14/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: TERUMO: 0.035" ADVANTAGE GLIDEWIRE.; TERUMO: 9F PINNACLE INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White