MAUDE Adverse Event Report: ABBOTT VASCULAR INC. RHV; INTRODUCER, CATHETER

Catalog Number	23245
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the angioplasty procedure the rotating hemostatic valve blue seal separated and with the injections of the contrast the separated portion continued its way into the probe.The separated portion was removed with a guide.A new valve and probe were used to continue the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.Device history record (dhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.It is possible the cap was overtightened resulting in compromising the seal/o-ring; thus during use interaction with the probe resulted in the reported/noted seal/o-ring material separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted material separation cannot be determined.As reported, the separated portion was removed with a guide.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Additional Manufacturer Narrative
B1 correction: adverse event removed b2 correction: required intervention removed d1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated h6: health effect - impact code 4641 was removed, 2199 was added.
Event or Problem Description
Subsequent to the previously filed report, additional information reported that the separated portion remained in the body of the rhv and did not travel into the patient.Therefore, no intervention was performed.No additional information was provided.

• Brand Name: RHV
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19298382
• Report Number: 2024168-2024-05796
• Device Sequence Number: 12226365
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: (01)08717648013386(17)250131(10)60432794
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K934624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2024

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: 01/31/2025
• Device Catalogue Number: 23245
• Device Lot Number: 60432794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 08/07/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/19/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown