MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS COOK MEDICAL INC.; APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDE

Model Number	AUTH-18-300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report delayed due to esubmitter setup issues; communicated with fda regarding this delay (b)(6) 2021.
Event or Problem Description
A (b)(6) male patient underwent an intervention sfa cto in which the approach authority workhorse microwire guide, ,018 wire diameter, 300cm length, 6.5cm polymer length, 8cm taper length, g57804, was used.Tibial access, attempting to cross calcified cto of sfa with authority wire through 018 angled cxi.Prolapsed tip trying to push through cto, wire and catheter entered subintimal space.After a little bit of maneuvering a portion of the tip of the wire broke.Distal tip of the wire broke off and wedged into the subintimal space, md [the physician] decided to leave broken tip and not try to retrieve.
Additional Manufacturer Narrative
Date of this report: 23-sept-2021.

• Brand Name: COOK MEDICAL INC.
• Common Device Name: APPROACH AUTHORITY WORKHORSE MICROWIRE GUIDE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 12736325
• Report Number: 3008988055-2021-00002
• Device Sequence Number: 17282741
• Product Code: DQX
• UDI-Device Identifier: 00816840020777
• UDI-Public: (01)00816840020777(17)240412(10)9007497392
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191502
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: AUTH-18-300
• Device Catalogue Number: AUTH-18-300
• Device Lot Number: 9007497392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male