MAUDE Adverse Event Report: CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	532598C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the gold collars around a 5f 65cm 8 side holes (8sh) super torque marker bands (mb) diagnostic catheter should be every centimeter, but the several ones near the mid-portion became detached and clumped up.There was no reported patient injury.The device will not be returned for evaluation as it was already discarded.Photo of the device is available for review.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g4, h1, h2 complaint became non-reportable due to additional information received.Code (marker bands-dislodged) removed.Product evaluation show the marker bands did not dislodge.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12294883
• Report Number: 9616099-2021-04768
• Device Sequence Number: 3181484
• Product Code: DQO
• UDI-Device Identifier: 10705032012041
• UDI-Public: 10705032012041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K915836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 02/29/2024
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 18008144
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 09/18/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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